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

Phase 1 Active not recruiting 33 enrolled Berlin-Chemie Menarini

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2025-03-03
Primary completion: 2025-10-01
Completion: 2025-12-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tamsulosin	Other / unclassified	0.4 mg	—

Indications

No indication recorded.