NCT00865618已完成1 期
Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed 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
- 发起方
- Sandoz
- 入组人数
- 60
- 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 demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
1
Experimental
Eplerenone 50mg Tablets
干预措施: Eplerenone 50 mg Tablets Sandoz Inc., USA (Drug)
2
Active Comparator
INSPRA 50mg Tablets
干预措施: Inspra 50 mg Tablets GD Searle LLC, USA (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
时间窗: 10 days
次要结局
未报告次要终点
研究者
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