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Study identifier: NCT07156916 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Healthy Volunteer Male Subjects  ·  Sponsor: Berlin-Chemie AG Menarini Group

PhasePhase 1
Planned participants46
Who can joinMale, 18 Years to 45 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Kai Schumacher, MD  ·  +49 (0)30 6707  ·  kaischumacher@berlin-chemie.de

Anja Pagenkopf  ·  +49 6707  ·  apagenkopf@berlin-chemie.de

Always discuss trial participation with your own doctor first.

Locations (1)

"Tonus-Les" LLCYerevan, Ankuk Region, ArmeniaRecruiting

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Source record: clinicaltrials.gov/study/NCT07156916