A formulation comparison study in Healthy Volunteers to compare the pharmacokinetic of Tamsulosin Hydrochloride and Proscar (registered) when administered as part of a fixed dose combination to when they are administered separately as single doses.

Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: Subjects randomised to either Part 1 or Part 2 will receive the treatments listed below in an open‐label, randomised, crossover manner: Part 1 Volunteers will receive 2 treatments with at least 5 days in between Treatment A: oral single capsule of MK‐906A (fixed dose combination of 0.2mg Tamsulosin Hydrochloride and 5mg Proscar) & Treatment B: oral single 0.2mg capsule of tamsulosin hydrocholoride+oral single tablet 5mg Proscar (finasteride). The sequence in which the volunteers will receive the drug will be different and allocated randomly. Part 2 : Volunteers will receive 3 treatments with at least 5 days in between of Treatment C:oral single capsule 0.2mg tamsulosin hydrochloride+ oral single tablet 5 mg Proscar (Finasteride); Treatment D: oral single capsule 0.2 mg tamsulosin hydrochloride; Treatment E: oral single tablet 5 mg Proscar (finasteride). The sequence in which the volunteers will receive the drug will be different and allocated randomly. CONDITION: Formulation Comparison study PRIMARY OUTCOME: To compare the single dose pharmacokinetic (level of drug in your blood) profile of Proscar following administration of MK‐906A and co‐admnistration of corresponding doses of Proscar and tamsulosin hydrochloride as individual tablets. Bioanalytical assay of drug levels in blood. SECONDARY OUTCOME: To compare the single dose pharmacokinetic (level of drug in your blood) profile of tamsulosin hydrochloride following administration of MK‐906A and co‐admnistration of corresponding doses of Proscar and tamsulosin hydrochloride as individual tablets. Bioanalytical assay of drug levels in blood. INCLUSION CRITERIA: Healthy Caucasian Male subjects who have been non smoker for at least 6 months
Epistemonikos ID: 3506a979d325137e8ec3c9b8b9b77136709ce105
First added on: Aug 25, 2024