NCT07091669

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

A Prospective, Randomized, Open Label, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V. the Netherlands), in Healthy Adult Male Subjects, Under Fed Conditions

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Berlin-Chemie AG Menarini Group · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this Phase I study, the test medication (Tamsulosin hydrochloride 0.4 mg prolonged-release tablets by Snthon, Hispania SL, Spain) is compared to the reference medication ( Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg, prolonged-release film-coated tablets by Astellas Pharma Europe B.V., the Netherlands) in terms of bioequivalence of the tested formulation under fed conditions.

Conditions

• Healthy Volunteers
• Male

Interventions

Type	Name	Description
DRUG	Tamsulosin (0.4 mg/j)	Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain)
DRUG	Tamsulosin (0.4 mg/j)	Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-08-01
• Completion: 2025-11-22
• First posted: 2025-07-29
• Last updated: 2025-08-08

Locations

1 site across 1 country: Armenia