Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-04-21 @ 11:17 AM
Study NCT ID:
NCT01511757
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2012-01-13', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC)', 'timeFrame': 'pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 9, 12, 24, 48 and 72 hours post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Fluconazole', 'Crossover'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fed conditions.", 'detailedDescription': 'Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 16 healthy adult male volunteers. A total 15 subjects completed the clinical phase of the study. In each period, subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 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 fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.\n\nSubjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.\n\nSubjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.\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': 'NCT01511757', 'briefTitle': 'Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions', '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 Fluconazole Tablets 200 mg and PFIZER (DIFLUCAN) 200 MG in Healthy Males Under Fed Condition.", 'orgStudyIdInfo': {'id': 'AA01514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluconazole', 'description': "Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.", 'interventionNames': ['Drug: Fluconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diflucan', 'description': 'Diflucan 200 mg fluconazole tablets of Pfizer', 'interventionNames': ['Drug: Fluconazole']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ["Dr. Reddy's Laboratories"], 'description': 'Fluconazole Tablets, 200 mg', 'armGroupLabels': ['Fluconazole']}, {'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan (Pfizer)'], 'description': 'fluconazole 200 mg', 'armGroupLabels': ['Diflucan']}]}, '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': {'type': 'SPONSOR'}}}}