drugset / Trial / NCT00835666

Finasteride 5 mg Tablets Under Fasting Conditions

NCT00835666 ↗

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2002-06
Primary completion
2002-06
Completion
2002-06

Outcome

Met primary endpoint

registry Geometric Test/Ref Ratio x 100 98.5 (90% CI 92.6 to 105) NCT00835666 ↗

registry Geometric Test/Ref Ratio x 100 98.2 (90% CI 94.7 to 102) NCT00835666 ↗

registry Geometric Test/Ref Ratio x 100 98.4 (90% CI 94.9 to 102) NCT00835666 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Finasteride Small molecule 5 mg —

Indications

No indication recorded.