Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State

PHASE1CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

February 11, 2014

Primary Completion Date

January 2, 2015

Study Completion Date

January 2, 2015

Conditions
Urologic Diseases
Interventions
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 fed 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 fed condition

Trial Locations (1)

BT9 6AD

GSK Investigational Site, Belfast

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02058576 - Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State | Biotech Hunter | Biotech Hunter