MedTrace Logo

Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions

NCT06316336 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-03-18

No results posted yet for this study

Summary

Objectives:

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations

Study Design:

An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2.

Conditions

  • Healthy Vollunteer

Interventions

DRUG

Alfuzosin Hydrochloride 10 mg

Alfuzosin Hydrochloride 10 mg (test durg)

DRUG

Xatral® XL 10 mg

Xatral® XL 10 mg (reference drug)

Sponsors & Collaborators

  • Pharma Nueva

    lead INDUSTRY

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
2024-06-10
Primary Completion
2024-06-22
Completion
2024-06-28

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 NCT06316336 on ClinicalTrials.gov