A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 16, 2025

Primary Completion Date

August 1, 2025

Study Completion Date

November 22, 2025

Conditions
Healthy VolunteersMale
Interventions
DRUG

Tamsulosin (0.4 mg/j)

Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain)

DRUG

Tamsulosin (0.4 mg/j)

Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands

Trial Locations (1)

0037

"Tonus-Les LLC", Yerevan

All Listed Sponsors
lead

Berlin-Chemie AG Menarini Group

INDUSTRY

NCT07091669 - A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions | Biotech Hunter | Biotech Hunter