NCT00990301已完成1 期
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic® 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers 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
- 48
- 试验地点
- 1
- 主要终点
- Bioequivalence specified outcomes
研究概览
简要总结
The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, 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 assessments performed at screening
排除标准
- •Positive test results for HIV or Hepatitis B or C
- •History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs
研究组 & 干预措施
Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets
Experimental
干预措施: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. (Drug)
Uniretic® 15mg/25mg Tablets
Active Comparator
干预措施: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. (Drug)
Uniretic® 15mg/25mg Tablets
Active Comparator
干预措施: Uniretic® 15mg/25mg Tablets (Drug)
结局指标
主要结局
Bioequivalence specified outcomes
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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