NCT01511757

Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions

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 Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Fluconazole	Fluconazole Tablets, 200 mg
DRUG	Fluconazole	fluconazole 200 mg

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-06-01
• Completion: 2002-07-01
• First posted: 2012-01-19
• Last updated: 2012-01-19

Locations

1 site across 1 country: Canada