NCT02509104 - Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 30, 2015

Primary Completion Date

October 10, 2015

Study Completion Date

October 10, 2015

Conditions

Prostatic Hyperplasia

Interventions

DRUG

FDC capsule of dutasteride and tamsulosin

Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.

DRUG

Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet

Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.

Trial Locations (1)

21225

GSK Investigational Site, Baltimore