Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions

NCT ID: NCT01511757

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2002-07-31

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 fed conditions.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluconazole

Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited.

Group Type: EXPERIMENTAL

Fluconazole

Intervention Type: DRUG

Fluconazole Tablets, 200 mg

Diflucan

Diflucan 200 mg fluconazole tablets of Pfizer

Group Type: ACTIVE_COMPARATOR

Fluconazole

Intervention Type: DRUG

fluconazole 200 mg

Interventions

Fluconazole

Fluconazole Tablets, 200 mg

Intervention Type: DRUG

Fluconazole

fluconazole 200 mg

Intervention Type: DRUG

Other Intervention Names

Dr. Reddy's Laboratories; Diflucan (Pfizer)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Cohen Street, Saint-laurent, Montreal (quebec), , Canada

Countries

Canada

Other Identifiers

AA01514

Identifier Type: -

Identifier Source: org_study_id