Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 Fasting Condition.|
- Area Under Curve (AUC) [ Time Frame: pre dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,4, 6, 9, 12, 24, 48 and 72 hours post-dose. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||September 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Fluconazole Tablets, 200 mg
Other Name: Dr. Reddy's Laboratories
Active Comparator: Diflucan
Diflucan 200 mg fluconazole tablets of Pfizer
Fluconazole 200 mg tablets
Other Name: Diflucan (Pfizer)
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.
|MDS Pharma Services|
|Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6|
|Principal Investigator:||Gaetano Morelli, MD||MDS Pharma Services|