Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00913718
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2009-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '1996-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1996-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on AUC and Cmax', 'timeFrame': '86 days'}]}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.\n\nExclusion Criteria:\n\n* Positive test results for HIV or hepatitis B or C.\n* Treatment for drug or alcohol dependence.'}, 'identificationModule': {'nctId': 'NCT00913718', 'briefTitle': 'To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fasting Conditions Following Administration of a 40 mg Dose', 'orgStudyIdInfo': {'id': '960380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)', 'interventionNames': ['Drug: Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)', 'interventionNames': ['Drug: Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)']}], 'interventions': [{'name': 'Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roderick Malone, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Center (Cincinnati)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D, VP of Product Development', 'oldOrganization': 'Sandoz Inc.'}}}}