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

Recruiting Phase 1 Interventional Study
Healthy Volunteer Male Subjects
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
46 (estimated)
Sponsor
Berlin-Chemie AG Menarini Group · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 2. Healthy male subjects aged 18 to 45 years inclusive, at the time of signing …
Contacts

Kai Schumacher, MD

+49 (0)30 6707

kaischumacher@berlin-chemie.de

CONTACT

Anja Pagenkopf

+49 6707

apagenkopf@berlin-chemie.de

CONTACT