NCT01264302

Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

A Randomized, Single-dose, Two-treatment, Two-way, Crossover Bioequivalence Study of Finasteride 5 mg Tablets (Dr. Reddy's Laboratories Limited) With the Reference Formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.) Under Fed Conditions in Healthy Adult Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck \& Co., Inc.)under fed conditions in healthy adult male subjects.

Detailed description

This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fed conditions. The study was conducted with 26 (24 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Finasteride	Finasteride Tablets 5 mg

Timeline

• Start date: 2006-11-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2010-12-21
• Last updated: 2010-12-21

Locations

1 site across 1 country: United States