Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Fluconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01511757

AA01514

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.