Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fluconazole

• Registration Number: NCT01511770
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2002-08
• Study Completion: 2002-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-19
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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),
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.
Diflucan	Fluconazole	Diflucan 200 mg fluconazole tablets of Pfizer

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	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.

Trial Locations

Locations (1)

MDS Pharma Services; 🇨🇦 Cohen street, saint-laurent, montreal (quebec), Canada