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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets; Drug: Xatral® XL 10 mg

• Registration Number: NCT06228339
• Lead Sponsor: International Bio service

Brief 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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-03-09
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xatral® XL 10 mg	Xatral® XL 10 mg	Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(Reference Drug)
Xatral® XL 10 mg	Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets	Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(Reference Drug)
Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets	Xatral® XL 10 mg	Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug)
Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets	Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets	Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug)

Primary Outcome Measures

Name	Time	Method
Plasma Area Under the Curve (AUC(0 to 48hr)) for Alfuzosin	Through 48 Hours Post Dose	Plasma Area Under the Curve of simvastatin acid, the active metabolite of Alfuzosin
Peak Plasma Concentration (Cmax) of Alfuzosin	48 Hours Post Dose	Peak Plasma Concentration (Cmax) of Alfuzosin