A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Status:
Completed
Trial end date:
2008-02-22
Target enrollment:
Participant gender:
Summary
This study will be an open-label, randomized, single dose, three way partial crossover study
in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose
combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram
[mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin
hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy
adult male subjects will be enrolled into the study. Subjects will receive single oral doses
in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC,
ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available
tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose
combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4
mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin
hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination
formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg
tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a
minimum 28 day washout period. The total duration of a subject's involvement in this study is
approximately 15-18 weeks.