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

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

February 19, 2014

Primary Completion Date

December 29, 2014

Study Completion Date

December 29, 2014

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 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.

Trial Locations (1)

BT9 6AD

GSK Investigational Site, Belfast

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02052713 - Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State | Biotech Hunter | Biotech Hunter