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临床试验/NCT06228339
NCT06228339尚未招募1 期

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

International Bio service0 个研究点目标入组 44 人开始时间: 2024年3月9日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
44
主要终点
Plasma Area Under the Curve (AUC(0 to 48hr)) for Alfuzosin

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

Experimental

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

干预措施: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Drug)

Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

Experimental

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

干预措施: Xatral® XL 10 mg (Drug)

Xatral® XL 10 mg

Active Comparator

Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(Reference Drug)

干预措施: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Drug)

Xatral® XL 10 mg

Active Comparator

Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(Reference Drug)

干预措施: Xatral® XL 10 mg (Drug)

结局指标

主要结局

Plasma Area Under the Curve (AUC(0 to 48hr)) for Alfuzosin

时间窗: Through 48 Hours Post Dose

Plasma Area Under the Curve of simvastatin acid, the active metabolite of Alfuzosin

Peak Plasma Concentration (Cmax) of Alfuzosin

时间窗: 48 Hours Post Dose

Peak Plasma Concentration (Cmax) of Alfuzosin

次要结局

未报告次要终点

研究者

发起方
International Bio service
申办方类型
Network
责任方
Sponsor

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