Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions
NCT01511770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2012-01-19
Summary
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 fasting conditions.
Conditions
- Healthy
Interventions
- DRUG
-
Fluconazole
Fluconazole Tablets, 200 mg
- DRUG
-
Fluconazole
Fluconazole 200 mg tablets
Sponsors & Collaborators
-
Dr. Reddy's Laboratories Limited
lead INDUSTRY
Principal Investigators
-
Gaetano Morelli, MD · MDS Pharma Services
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-08-31
- Primary Completion
- 2002-08-31
- Completion
- 2002-09-30
Countries
- Canada
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