Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions
NCT07698288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-07-13
Summary
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study
Conditions
- Bioequivalence
Interventions
- DRUG
-
Tamsulosin 0.4 mg ER tablet
TEST
- DRUG
-
Tamsulosin 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
- 2026-02-12
- Primary Completion
- 2026-04-16
- Completion
- 2026-04-16
Countries
- Mexico
Study Locations
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