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RECRUITING
NCT07156916
PHASE1

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

Sponsor: Berlin-Chemie AG Menarini Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-09-08

Completion Date

2026-05-01

Last Updated

2025-10-03

Healthy Volunteers

Yes

Interventions

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)

Locations (1)

"Tonus-Les" LLC

Yerevan, Ankuk Region, Armenia