NCT00871247

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions

Randomized, 2-Way Crossover Bioequivalence Study Finasteride 5 mg Tablet and Proscar Administrated as 1 x 5 mg Tablet in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck \& Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fed conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Finasteride 5 mg Tablet and Proscar Administered as 1 x 5 mg Tablet in Healthy Subjects Under Fed Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Finasteride 5 mg Tablet, single dose	A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fed conditions
DRUG	Proscar® 5 mg Tablet, single dose	B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fed conditions

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2009-03-30
• Last updated: 2010-08-16

Locations

1 site across 1 country: Canada