Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 8:58 PM
Study NCT ID:
NCT01703468
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078330', 'term': 'Oxcarbazepine'}], 'ancestors': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2012-10-05', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence determined by statistical comparison Cmax', 'timeFrame': '10 days', 'description': 'Blood sampling taken during specified time points to determine bioequivalence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seizures']}, 'descriptionModule': {'briefSummary': "The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening\n\nExclusion Criteria:\n\n* Positive test for HIV, Hepatitis B, or Hepatitis C.\n* Treatment with known enzyme altering drugs.\n* History of allergic or adverse response to oxcarbazepine or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT01703468', 'briefTitle': 'Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions', 'orgStudyIdInfo': {'id': 'OXCA-S600-PVFD-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxcarbazepine then Trileptal', 'description': '600 mg suspension', 'interventionNames': ['Drug: Oxcarbazepine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trileptal then Oxcarbazepine', 'description': '600 mg suspension', 'interventionNames': ['Drug: Oxcarbazepine']}], 'interventions': [{'name': 'Oxcarbazepine', 'type': 'DRUG', 'otherNames': ['Trileptal'], 'armGroupLabels': ['Oxcarbazepine then Trileptal', 'Trileptal then Oxcarbazepine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Cynthia Zamora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}