Study Comparing Bioavailability of Tamsulosin 0.4 mg Prolonged-Release Tablets and Omnic Ocas40 mg Film-Coated Tablets in Healthy Adult Men Under Fasting Conditions

What this Trial Is About

This research aims to compare two formulations of Tamsulosin hydrochloride 0.4 mg prolonged-release tablets to evaluate their bioequivalence and safety in healthy adult male volunteers. The study focuses on assessing how similarly the test medication from Synthon Hispania SL, Spain and the reference drug Omnic Ocas4 by Astellas Pharma Europe B.V., the Netherlands behave in the body when taken as a single dose under fasting conditions. This is a Phase I study involving healthy men aged 18 to 45 years. Participants will receive a single dose of either the test or reference Tamsulosin tablet with 240 ml of water while fasting. The study design includes a randomized, open-label, two-treatment, two-period, two-sequence crossover format, meaning each participant will receive both medications in different periods to allow direct comparison. The tablets differ in formulation one is a prolonged-release tablet and the other is a prolonged-release film-coated tablet. During the study, participants will undergo clinical, laboratory, and instrumental examinations to confirm health status and monitor effects. The primary outcomes measured include the maximum concentration Cmax and area under the curve AUC over specific timeframes to assess drug absorption and exposure. Secondary outcomes include various pharmacokinetic parameters such as time to maximum concentration Tmax and half-life t 12. The study lasts approximately 72 hours per dosing period with safety and adherence closely monitored by the research team.

A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions