NCT01929330

Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers

An Evaluation of the Bioequivalence of Five 0.1 mg GI198745/Dutasteride Soft Gelatin Capsules Compared to One 0.5 mg GI198745/Dutasteride Gelatin Capsules in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this study are expected to support registration applications for androgenetic alopecia (AGA) in Japan and other international markets.

Conditions

• Alopecia

Interventions

Type	Name	Description
DRUG	GI198745 0.1 mg	It is available as soft gelatin capsule to be administered as 5 X 0.1 mg capsules as single oral dose with approximately 250 mL of water.
DRUG	GI198745 0.5 mg	It is available as soft gelatin capsule to be administered as 1 X 0.5 mg capsules as single oral dose with approximately 250 mL of water.

Timeline

• Start date: 2013-09-23
• Primary completion: 2014-01-09
• Completion: 2014-01-09
• First posted: 2013-08-27
• Last updated: 2018-06-19

Locations

1 site across 1 country: Australia