Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-17 @ 4:03 PM
Study NCT ID:
NCT00847405
Status:
COMPLETED
Last Update Posted:
2009-09-11
First Post:
2009-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager, Biopharmaceutics', 'organization': 'TEVA Pharmaceuticals, USA'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator is not permitted to discuss or publish trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Sumatriptan)', 'description': '100 mg Sumatriptan Tablets test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Imitrex®)', 'description': '100 mg Imitrex® Tablets reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.26', 'spread': '14.45', 'groupId': 'OG000'}, {'value': '56.66', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '103.64', 'ciLowerLimit': '95.93', 'ciUpperLimit': '111.97', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on Cmax.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Sumatriptan)', 'description': '100 mg Sumatriptan Tablets test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Imitrex®)', 'description': '100 mg Imitrex® Tablets reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '258.76', 'spread': '76.55', 'groupId': 'OG000'}, {'value': '252.26', 'spread': '75.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '102.81', 'ciLowerLimit': '97.95', 'ciUpperLimit': '107.91', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on AUC0-t.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test (Sumatriptan)', 'description': '100 mg Sumatriptan Tablets test product dosed in either period.'}, {'id': 'OG001', 'title': 'Reference (Imitrex®)', 'description': '100 mg Imitrex® Tablets reference product dosed in either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '268.5', 'spread': '79.84', 'groupId': 'OG000'}, {'value': '260.47', 'spread': '78.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the T/R geometric mean x 100', 'ciPctValue': '90', 'paramValue': '103.25', 'ciLowerLimit': '98.35', 'ciUpperLimit': '108.41', 'estimateComment': 'Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\\<0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on AUC0-inf.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that completed the study had their samples analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test (Sumatriptan) First', 'description': '100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.'}, {'id': 'FG001', 'title': 'Reference (Imitrex®) First', 'description': '100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test (Sumatriptan) First', 'description': '100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.'}, {'id': 'BG001', 'title': 'Reference (Imitrex®) First', 'description': '100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.'}, {'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': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', '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': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-01', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-06', 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum Observed Concentration of Drug Substance in Plasma)', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on Cmax.'}, {'measure': 'AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on AUC0-t.'}, {'measure': 'AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)', 'timeFrame': 'Blood samples collected over a 12 hour period.', 'description': 'Bioequivalence based on AUC0-inf.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Non-smoking (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening) male or female within an age range of 18-40 years.\n* Body Mass Index (BMI = weight/height2) greater than 19 kg/m2 and less than 26 kg/m2.\n* Normal findings in the physical examination, vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-80 beats/min) and 12-lead ECG.\n* Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).\n* No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.\n* Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.\n\nExclusion Criteria\n\n* Known history of hypersensitivity to sumatriptan (e.g. Imitrex®, Imigran®) and/or related drugs such as almotriptan, naratriptan, rizatriptan and zolmitriptan\n* Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.\n* Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically significant illness during the last four weeks prior to entry into this study.\n* Presence of any significant physical or organ abnormality.\n* Any subject with a history of drug abuse.\n* Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.\n* Use of any prescription medication within 14 days preceding entry into this study.\n* Use of any monoamine oxidase (MAO) inhibitor drugs such as phenelzine or tranylcypromine within 30 days preceding entry into this study.\n* Use of over the counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).\n* Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.\n* Female subjects: presence of pregnancy or lactation.\n* Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.\n* Participation in a clinical trial with an investigational drug within 30 days preceding this study.\n* Any subject who has donated blood within 56 days preceding this study.\n* Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.\n* Significant or recent history of asthma (after 12 years of age).\n* Any subject with a recent (less than one year) history of alcohol abuse.\n* Known history of frequent headaches or migraines.\n* Any subject with a parental or sibling history of heart attack or stroke that occurred under the age of 40 years.\n* Intolerance to venipuncture.'}, 'identificationModule': {'nctId': 'NCT00847405', 'briefTitle': 'Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Two-Way Crossover, Open-Label, Single-Dose, Fasting Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets Versus Imitrex® 100 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects', 'orgStudyIdInfo': {'id': '2678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Sumatriptan Succinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Imitrex®']}], 'interventions': [{'name': 'Sumatriptan Succinate', 'type': 'DRUG', 'description': '100 mg Tablets', 'armGroupLabels': ['1']}, {'name': 'Imitrex®', 'type': 'DRUG', 'description': '100 mg Tablet', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M1L 4S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Biovail Contract Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Paul Y Tam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biovail Contract Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}