NCT01471678 - Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 7, 2011

Study Completion Date

September 7, 2011

Conditions

Prostatic Hyperplasia

Interventions

DRUG

Dutasteride (0.5mg)

This study is an open-label, randomized, single dose, four-period cross-over study.

DRUG

FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg)

FDC (with 10% enteric coated tamsulosin pellets); (2): FDC (with 15% enteric coated tamsulosin pellets);

DRUG

Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl)

a commercial formulation of dutasteride plus tamsulosin HCl (Harnal-D Tablet); (4): a commercial formulation of dutasteride plus tamsulosin HCl(Harnal Capsule). Each dosing session will be separated by a wash-out period of 5 to 10 days

Trial Locations (1)

2031

GSK Investigational Site, Randwick