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Clinical trial

A Prospective, Randomized, 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 Fed Conditions

NCT07091669 is registered in ClinicalTrials.gov with Berlin-Chemie AG Menarini Group as lead sponsor.

NCT NCT07091669
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Randomized, 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 Fed Conditions
Lead sponsor
Berlin-Chemie AG Menarini Group
Phase
Phase 1
Overall status
Active, not recruiting
Start date
June 16, 2025
Completion date
November 22, 2025
Enrollment
46 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteers, male