Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT02044367
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2014-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug date/time until the end-of-trial examination (last per protocol visit)', 'eventGroups': [{'id': 'EG000', 'title': 'T1 (Treatment A)', 'description': 'multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.', 'otherNumAtRisk': 54, 'otherNumAffected': 2, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'T2 (Treatment B)', 'description': 'multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.', 'otherNumAtRisk': 54, 'otherNumAffected': 3, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'R (Reference)', 'description': 'multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.', 'otherNumAtRisk': 54, 'otherNumAffected': 1, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'multiple dose of dabigatran (Pellets)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'multiple dose of dabigatran (Granules resolved in reconstitution solution)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG002', 'title': 'R (Reference)', 'description': 'multiple dose of dabigatran (Hard capsule)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1220', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '1160', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '893', 'spread': '46.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'gMean Ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '137.01', 'ciLowerLimit': '125.773', 'ciUpperLimit': '149.250', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '26.8', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'gMean Ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '130.43', 'ciLowerLimit': '119.628', 'ciUpperLimit': '142.200', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '27.1', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.', 'unitOfMeasure': 'ng∙h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'multiple dose of dabigatran (Pellets)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'multiple dose of dabigatran (Granules resolved in reconstitution solution)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG002', 'title': 'R (Reference)', 'description': 'multiple dose of dabigatran (Hard capsule)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '191', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '184', 'spread': '27.3', 'groupId': 'OG001'}, {'value': '131', 'spread': '50.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'gMean Ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '146.16', 'ciLowerLimit': '132.217', 'ciUpperLimit': '161.576', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '31.6', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'gMean Ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '141.06', 'ciLowerLimit': '127.644', 'ciUpperLimit': '155.876', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '31.5', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'multiple dose of dabigatran (Pellets)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'multiple dose of dabigatran (Granules resolved in reconstitution solution)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG002', 'title': 'R (Reference)', 'description': 'multiple dose of dabigatran (Hard capsule)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1000', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '958', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '727', 'spread': '50.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'gMean Ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '137.61', 'ciLowerLimit': '126.418', 'ciUpperLimit': '149.797', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '26.5', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'gMean Ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '132.00', 'ciLowerLimit': '120.714', 'ciUpperLimit': '144.342', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.0', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'SECONDARY', 'title': 'Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'multiple dose of dabigatran (Pellets)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'multiple dose of dabigatran (Granules resolved in reconstitution solution)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG002', 'title': 'R (Reference)', 'description': 'multiple dose of dabigatran (Hard capsule)\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'spread': '37.9', 'groupId': 'OG000'}, {'value': '154', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '106', 'spread': '55.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'gMean Ratio T1/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '147.80', 'ciLowerLimit': '133.384', 'ciUpperLimit': '163.779', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '32.4', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'gMean Ratio T2/R (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '144.80', 'ciLowerLimit': '130.853', 'ciUpperLimit': '160.242', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '32.0', 'estimateComment': 'The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).', 'groupDescription': "Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'SECONDARY', 'title': 'Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'I am not sure', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'once on day 3 (48 hours after first dose)', 'description': 'Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.'}, {'type': 'SECONDARY', 'title': 'Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (Treatment A)', 'description': 'T1: Pellets on food\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.'}, {'id': 'OG001', 'title': 'T2 (Treatment B)', 'description': 'T2: Granules resolved in reconstitution solution\n\nThe treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Not acceptable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'once on day 3 (48 hours after first dose)', 'description': 'Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T1-T2-R', 'description': 'T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'FG001', 'title': 'T1-R-T2', 'description': 'T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'FG002', 'title': 'T2-T1-R', 'description': 'T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'FG003', 'title': 'T2-R-T1', 'description': 'T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'FG004', 'title': 'R-T1-T2', 'description': 'R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}, {'id': 'FG005', 'title': 'R-T2-T1', 'description': 'R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The evaluation of demographic and baseline characteristics were performed on the treated set which included all subjects who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2014-01-22', 'resultsFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-10', 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.'}, {'measure': 'Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.'}, {'measure': 'Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.', 'timeFrame': '47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration', 'description': 'Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.'}, {'measure': 'Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.', 'timeFrame': 'once on day 3 (48 hours after first dose)', 'description': 'Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.'}, {'measure': 'Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.', 'timeFrame': 'once on day 3 (48 hours after first dose)', 'description': 'Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests\n2. Age 18 to 55 years (incl.)\n3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)\n4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation\n\nExclusion criteria:\n\n1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.\n2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease judged clinically relevant by the investigator\n5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug\n7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders\n8. Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:\n\n * Hemorrhagic disorders or bleeding diathesis\n * Occult blood in faeces or haematuria\n * Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation\n * History of arteriovenous malformation or aneurysm\n * History of gastroduodenal ulcer disease or gastrointestinal haemorrhage\n * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding\n * Anemia at screening\n * Thrombocytopenia (platelet count less than 100/nL)"}, 'identificationModule': {'nctId': 'NCT02044367', 'briefTitle': 'Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, Randomised, Multiple-dose, Three Way Crossover Study)', 'orgStudyIdInfo': {'id': '1160.194'}, 'secondaryIdInfos': [{'id': '2013-002498-23', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test 1 (Treatment A)', 'description': 'multiple dose of dabigatran', 'interventionNames': ['Drug: Dabigatran etexilate']}, {'type': 'EXPERIMENTAL', 'label': 'Test 2 (Treatment B)', 'description': 'multiple dose of dabigatran', 'interventionNames': ['Drug: Dabigatran etexilate']}, {'type': 'EXPERIMENTAL', 'label': 'Reference', 'description': 'multiple dose of dabigatran', 'interventionNames': ['Drug: Dabigatran etexilate']}], 'interventions': [{'name': 'Dabigatran etexilate', 'type': 'DRUG', 'description': 'Pellets (multiple dose of dabigatran)', 'armGroupLabels': ['Test 1 (Treatment A)']}, {'name': 'Dabigatran etexilate', 'type': 'DRUG', 'description': 'Granules resolved in reconstitution solution (multiple dose of dabigatran)', 'armGroupLabels': ['Test 2 (Treatment B)']}, {'name': 'Dabigatran etexilate', 'type': 'DRUG', 'description': 'Hard capsule (multiple dose of dabigatran)', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach', 'country': 'Germany', 'facility': '1160.194.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}