NCT06228339

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

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product (Xatral® XL 10 mg) in Healthy Thai Male Volunteers Under Fed Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: International Bio service · Network
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-03-09
• Primary completion: 2024-03-14
• Completion: 2024-03-21
• First posted: 2024-01-29
• Last updated: 2024-01-29