Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-30 @ 3:43 PM
Study NCT ID:
NCT01133457
Status:
COMPLETED
Last Update Posted:
2010-05-28
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-03', 'completionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-27', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-27', 'lastUpdatePostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on Cmax and AUC parameters', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence,Finasteride,Crossover'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \\& Co. (Propecia®)\n\n1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.", 'detailedDescription': 'Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nExclusion Criteria:\n\nHistory or presence of significant:\n\n• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.\n\nIn addition, history or presence of:\n\n* alcoholism or drug abuse within the past year;\n* hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor.\n\nSubjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.\n\nSubjects who, through completion of the study, would have donated in excess of:\n\n* 500 mL of blood in 14 days, or\n* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),\n* 1000 mL of blood in 90 days,\n* 1250 mL of blood in 120 days,\n* 1500 mL of blood in 180 days,\n* 2000 mL of blood in 270 days,\n* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.'}, 'identificationModule': {'nctId': 'NCT01133457', 'briefTitle': "Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition", 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': "Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.", 'orgStudyIdInfo': {'id': '012744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Finasteride', 'description': "Finasteride tablets 1 mg of Dr. Reddy's", 'interventionNames': ['Drug: Finasteride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propecia', 'description': 'Propecia 1 mgTablets of Merck \\& Co.,', 'interventionNames': ['Drug: Finasteride']}], 'interventions': [{'name': 'Finasteride', 'type': 'DRUG', 'otherNames': ['Propecia'], 'description': 'Finasteride tablets 1 mg', 'armGroupLabels': ['Finasteride', 'Propecia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4R 2N6', 'city': 'Cohen Street, Saint-laurent, Montreal (quebec)', 'country': 'Canada', 'facility': 'MDS Pharma Services'}], 'overallOfficials': [{'name': 'Gaetano Morelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MDS Pharma Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sr. Manager-Research and Development', 'oldOrganization': "Dr. Reddy's Laboratories Limited"}}}}