MedTrace Logo

Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fasted Conditions

NCT07698275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-07-13

No results posted yet for this study

Summary

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study

Conditions

  • Bioequivalance

Interventions

DRUG

TAMSULOSIN TEST

Tamsulosin 0.4 mg ER tablet, test

DRUG

OMNIC OCAS REFERENCE

Omnic Ocas, 0.4 mg, ER tablet, Reference

Sponsors & Collaborators

  • ADIUM

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-03-19
Completion
2026-03-19

Countries

  • Mexico

Study Locations

More Related Trials

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 NCT07698275 on ClinicalTrials.gov