NCT07156916

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

A Prospective, Randomised, 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 Fasting Conditions

• Status: 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 fasting conditions.

Detailed description

In this Phase I study, the test medication Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon 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 the tested formulations under fasting conditions.

Conditions

• Healthy Volunteer Male Subjects

Interventions

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

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-09-05
• Last updated: 2025-10-03

Locations

1 site across 1 country: Armenia