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

Summary

This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry. The aims are to:

* evaluate the pharmacokinetic parameters of several formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in the fasted state in order to define a formulation which is bioequivalent to a 0.2 mg orally disintegrating tamsulosin tablet, (Harnal-D Tablets)
* determine the effect of food on the relative bioavailability of tamsulosin in the FDC product which is assessed to be bioequivalent to Harnal-D Tablets in the fasted state
* assess the effect of water on the relative bioavailability of tamsulosin in Harnal-D Tablets in the fasted state
* assess the safety and tolerability of dosing with the different FDC capsule formulations Subjects will receive single oral doses in at least one treatment period; treatment periods will be separated by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate and review of adverse events. Each stage of the study will enrol 18 subjects to ensure 16 complete. Subjects may consent to participate in more than one stage.

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

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-11-06

Primary Completion

2012-04-03

Completion

2012-04-03

Countries

• Australia

Study Locations