Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2024-06-28

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Pharma Nueva

Treatments:

alfuzosin