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The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions

NCT06228339 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-01-29

No results posted yet for this study

Summary

Objective:

Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period.

Study Design:

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study

Conditions

  • Healthy Volunteer

Interventions

DRUG

Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug)

DRUG

Xatral® XL 10 mg

Xatral® XL 10 mg (Reference Drug)

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Porranee Puranajoti · International Bio service

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
2024-03-09
Primary Completion
2024-03-14
Completion
2024-03-21

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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 NCT06228339 on ClinicalTrials.gov