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

PHASE1RecruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

September 8, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

May 1, 2026

Conditions

Healthy Volunteer Male Subjects

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)

Trial Locations (1)

RECRUITING

"Tonus-Les LLC", Yerevan

All Listed Sponsors

lead

Berlin-Chemie AG Menarini Group

INDUSTRY