Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State
Status:
Completed
Trial end date:
2015-01-02
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the bioequivalence of the second generation
dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available
commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4 mg capsule
in healthy adult male subjects. Subjects in this study will receive either a single oral dose
of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a
single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL
0.4 mg capsule followed by a 28-day washout period both in fed state. The study will enroll
approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable
subjects. The total duration of a subject's involvement in this study is anticipated to be
approximately 12 weeks.