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

Phase 1 Active not recruiting 46 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), after single dose administration in healthy adult male subjects under fed conditions.

Timeline

Start: 2025-06-16
Primary completion: 2025-08-01
Completion: 2025-11-22

Drugs

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

Indications

No indication recorded.