IRCT20111107008022N10尚未招募未知
Comparative bioequivalence study of two different Fenofibrate 200mg formulations (Aviccena Pharmaceutical Company & reference) in 24 Iranian volunteers
Aviccena Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 years 至 40 years(—)
- 性别
- All
入选标准
- •Healthy male and female volunteers
- •Aged 18 to 45 years
- •Based on laboratory safety tests, no history of diseases affecting drug pharmacokinetic processes
- •lack of any chronic or acute medication at least 1 week before the start of the study
- •Actual weight (TBW) in the range of 20% IBW
排除标准
- •Subject showed clinically relevant deviations from normal in physical examination
- •Subject had undergone surgery of the gastrointestinal tract
- •Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment
- •Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day
- •Use any medication within 14 days before the first treatment
研究者
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