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Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated Tablets

NCT06558032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-16

No results posted yet for this study

Summary

This study was an open-label, randomized, single-dose, four-period, two-sequence, fully replicate study under fasting conditions which included 28 healthy adult male subjects. The objective of this study was to find out whether the bioavailability of tamsulosin 0.4 mg sustained release film coated tablet produced by PT Dexa Medica is equivalent to that of the comparator drug (Harnal® OCAS 0.4 mg Prolonged Release Tablet produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) when administered under fasting condition in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia)

One tablet of the test drug was given orally under fasting condition

DRUG

Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)

One tablet of the test drug was given orally under fasting condition

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2023-12-16
Completion
2024-02-07

Countries

  • Indonesia

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 NCT06558032 on ClinicalTrials.gov