NCT01495026 - A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 6, 2011

Primary Completion Date

April 3, 2012

Study Completion Date

April 3, 2012

Conditions

Prostatic Hyperplasia

Interventions

DRUG

Dutasteride (0.5mg, fasted state)

Open-label, randomized, single dose, multi-stage, cross-over study

DRUG

Dutasteride (0.5mg, fed state)

Commercial formulation of Dutasteride 0.5mg

DRUG

Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)

FDC with 85%, 65% and 0% of the dose as enteric-coated pellets and with X and/or Y% of the dose as enteric-coated pellets (X and Y to be determined from PK results from Stage 1)

DRUG

Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)

FDC containing faster-release enteric-coated pellets

DRUG

Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)

FDC bioequivalent to Harnal-D tablets

DRUG

Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fed state)

FDC bioequivalent to Harnal-D tablets

DRUG

Harnal-D Tablets with water (fasted state)

Commercial formulation of Harnal-D Tablets

DRUG

Harnal-D Tablets with water (fed state)

Commercial formulation of Harnal-D Tablets

DRUG

Harnal-D tablets without water (fasted state)

Commercial formulation of Harnal-D Tablets

Trial Locations (1)

2031

GSK Investigational Site, Randwick