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
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
- 是
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
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
Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug)
干预措施: Xatral® XL 10 mg (Drug)
Xatral® XL 10 mg
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
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
