Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-11 @ 2:53 PM
Study NCT ID:
NCT02232802
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'p.bettica@italfarmaco.com', 'phone': '+39 02 64431', 'title': 'Paolo Bettica, MD', 'organization': 'Chemi SpA (Part of Italfarmaco Group)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Throughout the study: day 1 (pre-dose,0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h), Day 2 (24 and 36h), and post-study follow-up. Follow-up assessments were classified as 'End of study assessments'. They were performed on Day 2, 36 h post-dose, prior to discharging the subject.", 'eventGroups': [{'id': 'EG000', 'title': 'Enoxaparin Sodium Chemi', 'description': 'Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.\n\nEnoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 7, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Clexane', 'description': 'Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.\n\nEnoxaparin Sodium: comparison of bioavailability of generic Enoxaparin Sodium and Clexane', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 5, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}], 'seriousEvents': [{'term': 'Fibrous dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0 / 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'categories': [{'measurements': [{'value': '0.8593', 'spread': '0.18056', 'groupId': 'OG000'}, {'value': '0.8698', 'spread': '0.20921', 'groupId': 'OG001'}]}]}, {'title': 'Anti-thrombin/factor IIa', 'categories': [{'measurements': [{'value': '0.1187', 'spread': '0.03451', 'groupId': 'OG000'}, {'value': '0.1296', 'spread': '0.03713', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean difference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.42', 'ciLowerLimit': '96.28', 'ciUpperLimit': '102.65', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Statistical comparison for Anti-FXa', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean difference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91.55', 'ciLowerLimit': '86.65', 'ciUpperLimit': '96.73', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Statistical comparison on Anti-FIIa', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'PRIMARY', 'title': 'AUC0-t (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'categories': [{'measurements': [{'value': '9.6259', 'spread': '1.68590', 'groupId': 'OG000'}, {'value': '9.3927', 'spread': '1.83943', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'categories': [{'measurements': [{'value': '1.0234', 'spread': '0.28817', 'groupId': 'OG000'}, {'value': '1.1097', 'spread': '0.31668', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean difference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '102.89', 'ciLowerLimit': '100.67', 'ciUpperLimit': '105.15', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FXa statistical comparison', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean difference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.37', 'ciLowerLimit': '87.72', 'ciUpperLimit': '97.25', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FIIa comparison', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII). thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa).\n\nAs enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'h*IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2789', 'spread': '1.71377', 'groupId': 'OG000'}, {'value': '9.9197', 'spread': '1.86143', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1489', 'spread': '0.29243', 'groupId': 'OG000'}, {'value': '1.2926', 'spread': '0.40401', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '104.26', 'ciLowerLimit': '101.68', 'ciUpperLimit': '106.9', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FXA comparison', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.44', 'ciLowerLimit': '85.38', 'ciUpperLimit': '95.8', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FIIa comparison', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'h*IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmax (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'categories': [{'measurements': [{'value': '4.0000', 'groupId': 'OG000', 'lowerLimit': '2.000', 'upperLimit': '6.000'}, {'value': '4.0000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '6.000'}]}]}, {'title': 'Anti-FIIa', 'categories': [{'measurements': [{'value': '4.0000', 'groupId': 'OG000', 'lowerLimit': '2.000', 'upperLimit': '6.000'}, {'value': '4.0000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '16.000'}]}]}], 'analyses': [{'pValue': '0.7642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'pValueComment': 'An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FXa comparison', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.'}, {'pValue': '0.9464', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'estimateComment': 'Geometric least square means are being compared.', 'groupDescription': 'Anti-FIIa comparison', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Tmax is the time to Cmax. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti-FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Lambda Zeta (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0962', 'spread': '0.04251', 'groupId': 'OG000'}, {'value': '0.1133', 'spread': '0.04337', 'groupId': 'OG001'}]}]}, {'title': 'Anti-IIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2111', 'spread': '0.10435', 'groupId': 'OG000'}, {'value': '0.1938', 'spread': '0.11612', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Lambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.\n\nBlood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 't1/2 (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4757', 'spread': '3.22737', 'groupId': 'OG000'}, {'value': '6.9507', 'spread': '2.42567', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6214', 'spread': '2.97971', 'groupId': 'OG000'}, {'value': '6.5045', 'spread': '8.67539', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'T1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmin (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'categories': [{'measurements': [{'value': '4.18', 'spread': '8.538', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '12.211', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Tmin is the time of Cmin. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC%ex (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4515', 'spread': '2.68130', 'groupId': 'OG000'}, {'value': '4.9683', 'spread': '1.80897', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0593', 'spread': '7.68842', 'groupId': 'OG000'}, {'value': '12.0906', 'spread': '9.02925', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.\n\nBlood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti-FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'percentage of total value of AUC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmin (Anti-FXa and Anti-FIIa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'title': 'Anti-FXa', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FIIa', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0044', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0042', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmin is the minimum plasma activity/concentration. Enoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4327', 'spread': '0.35998', 'groupId': 'OG000'}, {'value': '2.3391', 'spread': '0.33903', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '103.94', 'ciLowerLimit': '101.22', 'ciUpperLimit': '106.73', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4450', 'spread': '1.04983', 'groupId': 'OG000'}, {'value': '6.8546', 'spread': '0.95651', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '108.59', 'ciLowerLimit': '103.93', 'ciUpperLimit': '113.46', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. The ratio of anti-FXa/anti-FIIa activity was calculated for each parameter. Reults are presented as derived ratio of PK parameters.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-t (Derived Thrombin Generation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '3731.0710', 'spread': '1375.97298', 'groupId': 'OG000'}, {'value': '3597.3375', 'spread': '1104.52084', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '102.76', 'ciLowerLimit': '97.51', 'ciUpperLimit': '108.28', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.\n\nThrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.', 'unitOfMeasure': 'h*nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmin (Derived Thrombin Generation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.534', 'spread': '7.6300', 'groupId': 'OG000'}, {'value': '11.543', 'spread': '6.9299', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '114.91', 'ciLowerLimit': '102.29', 'ciUpperLimit': '129.08', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Thrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.\n\nCmin is the minimum plasma activity/concentration.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmin (Derived Thrombin Generation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '1.136', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '0.911', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.8554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Thrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample. Tmin is the time of Cmin.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-t (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1828', 'spread': '7.91060', 'groupId': 'OG000'}, {'value': '55.7851', 'spread': '8.43154', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.86', 'ciLowerLimit': '99.27', 'ciUpperLimit': '102.47', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.', 'unitOfMeasure': 'h*Unit/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '140.8383', 'spread': '36.06655', 'groupId': 'OG000'}, {'value': '173.9833', 'spread': '123.89404', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.13', 'ciLowerLimit': '85.7', 'ciUpperLimit': '105.6', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant.', 'unitOfMeasure': 'h*Unit/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmax (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7500', 'spread': '0.83178', 'groupId': 'OG000'}, {'value': '1.8068', 'spread': '1.20665', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.6857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.5', 'estimateComment': 'Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nTmax is the time to Cmax', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmin (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.261', 'spread': '0.2277', 'groupId': 'OG000'}, {'value': '1.290', 'spread': '0.2288', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nCmin is the minimum plasma activity/concentration.', 'unitOfMeasure': 'Unit/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmin (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '16.27', 'spread': '5.275', 'groupId': 'OG000'}, {'value': '15.55', 'spread': '6.293', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nTmin is the time of Cmin.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'T1/2 (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6397', 'spread': '8.66880', 'groupId': 'OG000'}, {'value': '57.2439', 'spread': '46.13993', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nT1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Lambda Zeta (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0172', 'spread': '0.00323', 'groupId': 'OG000'}, {'value': '0.0148', 'spread': '0.00440', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI)\\[5\\], which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nLambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC%ex (Tissue Factor Pathway Inhibitor, TFPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9149', 'spread': '5.07416', 'groupId': 'OG000'}, {'value': '63.0497', 'spread': '8.81000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also release tissue factor pathway inhibitor (TFPI)\\[5\\], which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.', 'unitOfMeasure': 'percentage of total AUC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-t (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7836', 'spread': '1.75225', 'groupId': 'OG000'}, {'value': '8.7967', 'spread': '1.64043', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '111.39', 'ciLowerLimit': '105.89', 'ciUpperLimit': '117.17', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.', 'unitOfMeasure': 'h*IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1620', 'spread': '1.47121', 'groupId': 'OG000'}, {'value': '8.2160', 'spread': '1.60673', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least square mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '113.82', 'ciLowerLimit': '107.47', 'ciUpperLimit': '120.53', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant', 'unitOfMeasure': 'h*IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'T1/2 (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6595', 'spread': '2.06574', 'groupId': 'OG000'}, {'value': '1.9420', 'spread': '1.47865', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nT1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmin (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nCmin is the minimun plasma activity/concentration.', 'unitOfMeasure': 'UI/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmin (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nTmin is the time of Cmin.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUC%ex (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8078', 'spread': '0.71131', 'groupId': 'OG000'}, {'value': '0.6385', 'spread': '0.52118', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.', 'unitOfMeasure': 'percentage of total AUC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmax (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9973', 'spread': '0.28432', 'groupId': 'OG000'}, {'value': '0.9830', 'spread': '0.24467', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.9217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.13', 'estimateComment': 'Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.'}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nTmax is the time to Cmax.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Lambda Zeta (Anti-FXa/Anti-FIIa Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enoxaparin Sodium Chemi (Test IMP)', 'description': 'Enoxaparin Sodium Chemi (i.e. Test IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}, {'id': 'OG001', 'title': 'Clexane (Reference IMP)', 'description': 'Clexane (i.e. Reference IMP) was administered to healthy subjects. A single dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection. It was administered s.c . into the right or left side of the abdomen (alternating sides with treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6699', 'spread': '0.52191', 'groupId': 'OG000'}, {'value': '1.0937', 'spread': '1.82862', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nLambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: All subjects who received study medication in both treatment periods, had sufficient plasma activity/concentration-time profiles and who did not violate the protocol in such a way that may have invalidated or biased the results (major protocol violators) were included in the PK analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test IMP - Reference IMP', 'description': 'These patients reveiced the following sequence:\n\nTest IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).\n\nEach dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.\n\nSubjects remained in an upright position whilst receiving each dose and for 4 h afterwards.\n\nThere were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential. Female subjects of child bearing potential underwent a washout period of approximately 28 days.'}, {'id': 'FG001', 'title': 'Reference IMP - Test IMP', 'description': 'These patients reveiced the following sequence:\n\nReference IMP: A single-dose of 80mg/0.8 mL Clexane® Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).\n\nEach dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.\n\nSubjects remained in an upright position whilst receiving each dose and for 4 h afterwards.\n\nThere were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential.\n\nFemale subjects of child bearing potential underwent a washout period of approximately 28 days.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Forty-seven (47) subjects (23 male and 24 female) were enrolled in the study. The subjects were selected from a large panel who offered their services as healthy volunteers for the purpose of undertaking REC and Regulatory Authority-approved studies on drug safety, absorption and disposition.', 'preAssignmentDetails': 'The study comprised a screening visit and 2 treatment periods. Only two doses were scheduled to be administered: first dose (period 1) - wash out (at least 7 days) - 2nd dose (period 2) - wash out period (at least 7 days). Each treatment period was of 2 days duration. Screening assessments: from Day -14 to Day -1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test IMP - Reference IMP', 'description': 'These patients reveiced the following sequence:\n\nTest IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Reference IMP: A single-dose of 80mg/0.8 mL Clexane® Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).\n\nEach dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.\n\nSubjects remained in an upright position whilst receiving each dose and for 4 h afterwards.\n\nThere were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential. Female subjects of child bearing potential underwent a washout period of approximately 28 days.'}, {'id': 'BG001', 'title': 'Reference IMP - Test IMP', 'description': 'These patients reveiced the following sequence:\n\nReference IMP: A single-dose of 80mg/0.8 mL Clexane® Test IMP: A single-dose of 80mg/0.8 mL Chemi Enoxaparin. Each dose was administered s.c. into the left or right side of the abdomen (alternating sides with treatment period).\n\nEach dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti-FXa activity) in 0.8 mL water for injection.\n\nSubjects remained in an upright position whilst receiving each dose and for 4 h afterwards.\n\nThere were at least 7 days between each dose administration for males and female subjects of nonchildbearing potential.\n\nFemale subjects of child bearing potential underwent a washout period of approximately 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2014-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2014-09-03', 'resultsFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-19', 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'AUC0-t (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII). thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa).\n\nAs enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}], 'secondaryOutcomes': [{'measure': 'AUC0-inf (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'Tmax (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Tmax is the time to Cmax. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti-FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'Lambda Zeta (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Lambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.\n\nBlood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 't1/2 (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'T1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'Tmin (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Tmin is the time of Cmin. Blood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'AUC%ex (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.\n\nBlood samples (2 x 10 mL) for determination of plasma anti-FIIa and anti-FXa were collected from a forearm vein into a Citrate Sarstedt Monovette at the following time-points (at day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)) and kept frozen until analysis.\n\nEnoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti-FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'Cmin (Anti-FXa and Anti-FIIa)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmin is the minimum plasma activity/concentration. Enoxaparin exerts its anti-coagulant effect primarily via interaction with anti-thrombin III (ATIII), thereby enhancing the inhibitory effect of ATIII on activated factor Xa (FXa) and thrombin/factor IIa (FIIa). As enoxaparin cannot be measured directly in blood, the PK of enoxaparin have been studied on the basis of its effect on clotting mechanisms, particularly the inhibition of FXa (anti-FXa) and FIIa (anti- FIIa) activity. Results are presented as derived plasma PK parameters.'}, {'measure': 'Cmax (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.'}, {'measure': 'Cmax (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Cmax is the maximum measured plasma activity/concentration. The ratio of anti-FXa/anti-FIIa activity was calculated for each parameter. Reults are presented as derived ratio of PK parameters.'}, {'measure': 'AUC0-t (Derived Thrombin Generation)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'AUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.\n\nThrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.'}, {'measure': 'Cmin (Derived Thrombin Generation)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Thrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.\n\nCmin is the minimum plasma activity/concentration.'}, {'measure': 'Tmin (Derived Thrombin Generation)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Thrombin generated in the thrombin generation test can be quantified as platelet-rich or platelet-poor plasma using the calibrated automated thrombogram method, which monitors the cleavage of a fluorogenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample. Tmin is the time of Cmin.'}, {'measure': 'AUC0-t (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.'}, {'measure': 'AUC0-inf (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant.'}, {'measure': 'Tmax (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nTmax is the time to Cmax'}, {'measure': 'Cmin (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nCmin is the minimum plasma activity/concentration.'}, {'measure': 'Tmin (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nTmin is the time of Cmin.'}, {'measure': 'T1/2 (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI), which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nT1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.'}, {'measure': 'Lambda Zeta (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also releases tissue factor pathway inhibitor (TFPI)\\[5\\], which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nLambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.'}, {'measure': 'AUC%ex (Tissue Factor Pathway Inhibitor, TFPI)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'Enoxaparin also release tissue factor pathway inhibitor (TFPI)\\[5\\], which is thought to contribute to anti-coagulant activity, by inhibiting FXa generation and free FXa.\n\nAUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.'}, {'measure': 'AUC0-t (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC0-t is the area under the plasma activity/concentration-time curve from the time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.'}, {'measure': 'AUC0-inf (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC0-inf is the area under the activity/concentration-time curve from time 0 extrapolated to infinity. It was calculated as the sum of AUC0-t plus the ratio of the last measurable value to the elimination rate constant'}, {'measure': 'T1/2 (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nT1/2 is the apparent first-order terminal elimination half-life calculated as 0.693/kel.'}, {'measure': 'Cmin (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nCmin is the minimun plasma activity/concentration.'}, {'measure': 'Tmin (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nTmin is the time of Cmin.'}, {'measure': 'AUC%ex (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nAUC%ex is the residual area, i.e. the percentage of the area under the curve (AUC) extrapolated to infinity observed from Tlast to infinity.'}, {'measure': 'Tmax (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nTmax is the time to Cmax.'}, {'measure': 'Lambda Zeta (Anti-FXa/Anti-FIIa Ratio)', 'timeFrame': 'At day 1(0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16h) and Day 2 (24 and 36h)', 'description': 'The ratio of anti-FXa/anti-FIIa activity was calculated for each major parameter.\n\nLambda zeta is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma activity/concentration vs time curve.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Enoxaparin Sodium is Administered to Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.\n* The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.', 'detailedDescription': 'This is an open-label, randomised, single-dose, 2-way crossover study to determine the comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL) with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose administration in healthy male and female subjects.\n\nEach subject received each treatment over two separate treatment periods under fasting conditions. Each dosing day for male subjects will be separated by a washout period of at least 7 days. The study comprised a pre-study screen (within 14 days of the first dose), followed by 2 Treatment Periods (1 and 2). During each treatment period, subjects will reside at Simbec from the evening before dosing (Day 1), until at least 36 h post dose (evening of Day 2). On admission (Day -1), subjects will provide a urine sample for a drugs of abuse screen; this sample will also be tested to confirm a negative pregnancy result in female volunteers.\n\nA single dose of the randomised treatment will be given on the morning of Day 1 following an overnight fast and blood PK/PD samples collected from pre-dose up to 36 h post dose (14 samples). Safety will also be evaluated at specified times throughout the study.\n\nThe post study visit will be conducted on Day 2 (36 h post-dose) of Treatment Period 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female volunteer between 18 and 55 years of age.\n* Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / \\[Height (m)\\]2)\n* Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.\n* Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) and vital signs determined within 14 days of the first dose.\n* Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV) results.\n\nExclusion Criteria:\n\n* Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.\n* Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug abuse;\n* Subject with clinically relevant abnormal physical findings or clinically relevant abnormal laboratory values indicative of physical illness;\n* Female subject who is pregnant or lactating\n* Female subject with weight \\< 45 kg or male subject with weight \\< 57 kg.'}, 'identificationModule': {'nctId': 'NCT02232802', 'briefTitle': 'Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chemi S.p.A.'}, 'officialTitle': 'Comparative, Randomized, Single-dose, 2-way Cross Over Bioavailability Study of Enoxaparin Sodium Chemi (80 mg/0.8mL) and Clexane® (80 mg/0.8mL) s.c. in Healthy Adult Subjects Under Fasting Conditions.', 'orgStudyIdInfo': {'id': 'ENOXA/14/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enoxaparin Sodium Chemi', 'description': 'Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.', 'interventionNames': ['Drug: Enoxaparin Sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Clexane', 'description': 'Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.', 'interventionNames': ['Drug: Enoxaparin Sodium']}], 'interventions': [{'name': 'Enoxaparin Sodium', 'type': 'DRUG', 'otherNames': ['Clexane'], 'description': 'comparison of bioavailability of generic Enoxaparin Sodium and Clexane', 'armGroupLabels': ['Enoxaparin Sodium Chemi']}, {'name': 'Enoxaparin Sodium', 'type': 'DRUG', 'otherNames': ['generic Enoxaparin Sodium'], 'description': 'comparison of bioavailability of generic Enoxaparin Sodium and Clexane', 'armGroupLabels': ['Clexane']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF48 4DR', 'city': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Simbec Research Ltd', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'overallOfficials': [{'name': 'Paolo Bettica, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Italfarmaco S.p.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chemi S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}