Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT00905567
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2009-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topiramate 25 mg Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
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All analyses were performed according to FDA's guidleines."}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study was included in statistical analysis.', 'anticipatedPostingDate': '2009-05'}, {'type': 'PRIMARY', 'title': 'AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Topiramate 2 x 25 mg Tablet'}, {'id': 'OG001', 'title': 'Topamax®', 'description': 'Topamax® Tablet 2 x 25 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '20792.34', 'spread': '7701.94', 'groupId': 'OG000'}, {'value': '21930.92', 'spread': '9118.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the Least Squares Mean', 'ciPctValue': '90', 'paramValue': '96.62', 'estimateComment': 'Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines."}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on AUC0-72', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study was included in the statistical analysis.', 'anticipatedPostingDate': '2009-05'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Topiramate 2 x 25 mg Tablet'}, {'id': 'OG001', 'title': 'Topamax®', 'description': 'Topamax® Tablet 2 x 25 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '23634.03', 'spread': '8515.55', 'groupId': 'OG000'}, {'value': '24918.64', 'spread': '9927.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the Least Squares Mean', 'ciPctValue': '90', 'paramValue': '96.43', 'estimateComment': 'Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines."}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study was used in the statistical analysis.', 'anticipatedPostingDate': '2009-05'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topiramate (Test) First', 'description': 'Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Topamax® (Reference) First', 'description': 'Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topiramate (Test) First', 'description': 'Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Topamax® (Reference) First', 'description': 'Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in 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': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', '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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-14', 'studyFirstSubmitDate': '2009-05-18', 'resultsFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-14', 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on AUC0-72'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 96 hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be females and/or males, non-smokers, 18 years of age or older\n* Subjects should read, sign and date an Informed Consent Form prior to any study procedures.\n* Female subjects will be post-menopausal or surgically sterilized.\n* Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.\n* Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.\n\nExclusion Criteria:\n\n* Clinically significant illnesses within 4 weeks of the administration of study medication.\n* Clinically significant surgery within 4 weeks prior to the administration of the study medication.\n* Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.\n* Any clinically significant abnormality found during medical screening.\n* Abnormal laboratory tests judged clinically significant.\n* Positive urine drug screen at screening.\n* Positive alcohol breath test at screening.\n* Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence is required.\n* Positive testing for hepatitis B, hepatitis C or HIV at screening.\n* ECG or vital sign abnormalities (clinically significant).\n* Subjects with BMI greater than or equal to 30.0.\n* History of significant alcohol abuse within 6 months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).\n* History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.\n* Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subjects participation in this study.\n* History of allergic reactions to topiramate.\n* Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.\n* Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.\n* Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.\n* Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.\n\nAdditional exclusion criteria for females only:\n\n• Positive urine pregnancy test at screening (performed on all females).'}, 'identificationModule': {'nctId': 'NCT00905567', 'briefTitle': 'Topiramate 25 mg Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fed Conditions', 'orgStudyIdInfo': {'id': '01178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test First', 'description': 'Topiramate 2 x 25 mg Tablet', 'interventionNames': ['Drug: Topiramate 2 x 25 mg tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference First', 'description': 'Topamax® Tablet 2 x 25 mg', 'interventionNames': ['Drug: Topamax® Tablet 2 x 25 mg']}], 'interventions': [{'name': 'Topiramate 2 x 25 mg tablet', 'type': 'DRUG', 'armGroupLabels': ['Test First']}, {'name': 'Topamax® Tablet 2 x 25 mg', 'type': 'DRUG', 'armGroupLabels': ['Reference First']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 2K8', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Anapharm Inc.', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'Benoit Girard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anapharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}