Bioequivalence - Duodart Against Avodart & Omnic

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 23, 2012

Primary Completion Date

December 5, 2012

Study Completion Date

December 5, 2012

Conditions
Prostatic Hyperplasia
Interventions
DRUG

dutasteride/tamsulosin

Duodart® 0.5 mg / 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

DRUG

dutasteride

Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

DRUG

tamsulosin

Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

Trial Locations (1)

143964

GSK Investigational Site, Reutov, Moscow Region

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01657851 - Bioequivalence - Duodart Against Avodart & Omnic | Biotech Hunter | Biotech Hunter