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

Phase 1 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 fasting conditions.

Timeline

Start: 2025-09-08
Primary completion: 2026-03-01
Completion: 2026-05-01

Drugs

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

Indications

No indication recorded.