NCT07146711

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

A Prospective, Randomised, Open Label, Multiple 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, at Steady State

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• 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), in healthy adult male subjects, at steady state.

Detailed description

The assessment of the bioequivalence of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), and Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands) after multiple dose administration in healthy male subjects at steady state.

Conditions

• Healthy Adult Males Volunteers

Interventions

Type	Name	Description
DRUG	Tamsulosin (0.4 mg/j)	Multiple dose administration (7 days)
DRUG	Omnic Ocas®,	Multiple dose administration (7 days)

Timeline

• Start date: 2025-03-03
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Armenia