NCT02052713

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State

A Single-Dose, Randomised, Open-Label, Two-Period Crossover Study to Determine the Bioequivalence of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in the Fasted State in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligram (mg) and tamsulosin HCL 0.4 mg capsule in healthy adult male subjects. Subjects in this study will receive either a single oral dose of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg followed by a 28-day washout period both in fasted state. The study will enroll approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable subjects. The total duration of a subject's involvement in this study is anticipated to be approximately 12 weeks.

Conditions

• Urologic Diseases

Interventions

Type	Name	Description
DRUG	Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg	Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fasted condition.
DRUG	Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule	Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fasted condition.

Timeline

• Start date: 2014-02-19
• Primary completion: 2014-12-29
• Completion: 2014-12-29
• First posted: 2014-02-03
• Last updated: 2018-09-13

Locations

1 site across 1 country: United Kingdom