Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

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),

• 1000 mL of blood in 90 days,

• 1250 mL of blood in 120 days,

• 1500 mL of blood in 180 days,

• 2000 mL of blood in 270 days,

• 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.