Overview

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

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2025-11-22

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Berlin-Chemie AG Menarini Group

Treatments:

Tamsulosin