Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated October 3, 2025 (before its estimated March 1, 2026 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), after single dose administration in healthy adult male subjects under fasting conditions.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-04.
Status change: Not Yet Recruiting → Recruiting 2025-10-02
Trial Details
NCT Number NCT07156916
Lead Sponsor Berlin-Chemie AG Menarini Group
Conditions Healthy Volunteer Male Subjects
Enrollment 46 participants
Start Date 2025-09-08
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-03