Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT00864006
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting 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': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence according to US FDA Guidelines', 'timeFrame': '9 Days'}]}, 'conditionsModule': {'conditions': ['Seizures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant findings on physical examination, medical history or laboratory tests on screening\n\nExclusion Criteria:\n\n* Positive test for HIV or Hepatitis B and C\n* History of sensitivity to valproic acid or related compounds'}, 'identificationModule': {'nctId': 'NCT00864006', 'briefTitle': 'Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': '2006-1294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Divalproex Sodium 125 MG Delayed Release Tablets Sandoz', 'interventionNames': ['Drug: Divalproex Sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Depakote 125 MG DR Tablets Abbott Laboratories USA', 'interventionNames': ['Drug: Depakote DR Tablets']}], 'interventions': [{'name': 'Divalproex Sodium', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Depakote DR Tablets', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xueyu Chen, MD, Ph.D, FRCP(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharma Medica Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mitleberg. Ph.D., VP Product Development', 'oldOrganization': 'Sandoz, Inc.'}}}}