Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 3:47 AM
Study NCT ID:
NCT00649467
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2008-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2008-03-30', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.', 'timeFrame': 'blood collections through 144 hours'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mpibiostudies.com', 'label': 'Mylan Pharmaceuticals Inc. - Clinical Trial Results'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/about.cfm', 'label': 'Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'Recalls, Market Withdrawals and Safety Alerts'}]}, 'descriptionModule': {'briefSummary': "The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, adult subjects, 18 years and older\n* able to swallow medication\n\nExclusion Criteria:\n\n* institutionalized subjects\n* history of any significant disease\n* use of any prescription or OTC medications within 14 days of start of study\n* received any investigational products within 30 days prior to start of study'}, 'identificationModule': {'nctId': 'NCT00649467', 'briefTitle': 'Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce', 'orgStudyIdInfo': {'id': 'TOPR-0585'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Topiramate Sprinkle Capsules 25 mg', 'interventionNames': ['Drug: Topiramate Sprinkle Capsules 25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Topamax® Sprinkle Capsules 25 mg', 'interventionNames': ['Drug: Topamax® Sprinkle Capsules 25 mg']}], 'interventions': [{'name': 'Topiramate Sprinkle Capsules 25 mg', 'type': 'DRUG', 'description': '25mg, single dose applesauce', 'armGroupLabels': ['1']}, {'name': 'Topamax® Sprinkle Capsules 25 mg', 'type': 'DRUG', 'description': '25mg, single dose applesauce', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Kendle International Inc.', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Dorian Williams, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kendle International Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wayne Talton', 'oldOrganization': 'Mylan Inc.'}}}}