Clinical Trial

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

Active, Not Recruiting Phase 1
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Summary
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), after single dose administration in healthy adult male subjects under fed conditions.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-22; most recent amendment 2025-08-07.
Status change: Recruiting → Active, Not Recruiting 2025-08-07
Trial Details
NCT Number NCT07091669
Lead Sponsor Berlin-Chemie AG Menarini Group
Conditions Healthy Volunteers, Male
Enrollment 46 participants
Start Date 2025-06-16
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-11-22 (estimated)
Updated on ClinicalTrials.gov 2025-08-08