NCT00834379已完成1 期
A Relative Bioavailability Study of Pravastatin Sodium 40 mg 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
- 58
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC
研究概览
简要总结
The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 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
Pravastatin
Experimental
Pravastatin 40 mg Tablet (test) dosed in first period followed by Pravachol® 40 mg Tablet (reference) dosed in second period
干预措施: pravastatin sodium (Drug)
Pravachol®
Active Comparator
Pravachol® 40 mg Tablet (reference) dosed in first period followed by Pravastatin 40 mg Tablet (test) dosed in second period
干预措施: Pravachol® (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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