Clinical Trial

A Comparative Bioavalability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tabsulosine 0.4 mg Tablets in Healthy Adult Male Subjects, at Steady State

Active, Not Recruiting Phase 1
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Record status
This record was last updated August 28, 2025 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
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), in healthy adult male subjects, at steady state.
Trial Details
NCT Number NCT07146711
Lead Sponsor Berlin-Chemie AG Menarini Group
Conditions Healthy Adult Males Volunteers
Enrollment 33 participants
Start Date 2025-03-03
Primary Completion 2025-10-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-28