Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.
Status:
Completed
Trial end date:
2011-09-07
Target enrollment:
Participant gender:
Summary
This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a
fixed dose combination 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 or capsules. Two fixed dose combination capsules will be tested; one will contain
tamsulosin hydrochloride pellets with a 15% enteric coating, and the other tamsulosin
hydrochloride pellets with a 10% enteric coat. In addition, two formulations of tamsulosin
hydrochloride will be tested in the co-administration with dutasteride 0.5 mg; a 0.2 mg oral
disintegrating tablet and a 0.2 mg hard shell capsule. This will be an open-label,
randomized, single dose, four-period crossover in healthy male subjects of North East Asian
ancestry. Subjects will receive single oral doses in four treatment periods, each 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. The study will enrol approximately 30 healthy male
subjects to ensure that 24 complete the study.