NCT01133444

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition

Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia Under Fasting Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®) 1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.

Detailed description

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Finasteride	Finasteride tablets 1 mg

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-04-01
• Completion: 2002-05-01
• First posted: 2010-05-28
• Last updated: 2010-07-12

Locations

1 site across 1 country: Canada