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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

NCT07156916 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

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)

Sponsors & Collaborators

  • Berlin-Chemie AG Menarini Group

    lead INDUSTRY

Principal Investigators

  • Shougher Heboyan, MD · "Tonus-Les" LLC, 2/1 Varshavyan street. 0037 Yerewan, Armenia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-03-01
Completion
2026-05-01

Countries

  • Armenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156916 on ClinicalTrials.gov