NCT00835666

Finasteride 5 mg Tablets Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Finasteride 5 mg tablets	1 x 5 mg, single dose fasting
DRUG	PROSCAR®	1 x 5 mg, single dose fasting

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2009-02-04
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States