NCT00992862已完成1 期
A Relative Bioavailability Study of Moexipril HCl 15mg Tablets Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bioequivalence according to US FDA guidelines
研究概览
简要总结
The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening
排除标准
- •Positive test results for HIV or Hepatitis B or C
- •History of allergy or sensitivity to Moexipril HCl or related drugs
研究组 & 干预措施
Moexipril HCl 15mg Tablets
Experimental
干预措施: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc. (Drug)
Univasc® 15mg Tablets
Active Comparator
干预措施: Univasc® 15mg Tablets (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
次要结局
未报告次要终点
研究者
研究点 (1)
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