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.
Overview
- Phase
- Phase 1
- Intervention
- Fluconazole
- Conditions
- Healthy
- Sponsor
- Dr. Reddy's Laboratories Limited
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Area Under Curve (AUC)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •History or presence of significant:
- •cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past year;
- •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.
- •Subjects 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.
- •Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.
- •Subjects who, through completion of the study, would have donated in excess of:
- •500 mL of blood in 14 days, or
- •500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
Arms & Interventions
Fluconazole
Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Intervention: Fluconazole
Diflucan
Diflucan 200 mg fluconazole tablets of Pfizer
Intervention: Fluconazole
Outcomes
Primary Outcomes
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.