IRCT20190706044111N12已完成未知
An open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Aristatin 5 mg tablet of Arya Pharm Co., IRAN and Crestor 5 mg tablet of Astra-Zeneca in 24 healthy adult subjects under fasting condition
Arya Pharm 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
- 已完成
- 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
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •Aged between 18 - 50 years
- •- Body weight between 50 – 100 kg
- •- Having good health on the basis of medical history and physical & clinical examination
- •- Understand the procedures and give written informed consent
排除标准
- •Subject showed clinically relevant deviations from normal in physical examination.
- •Subject had undergone surgery of the gastro-intestinal 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 drug or alcohol abuse.
- •Subject who smokes more than 10 cigarettes per day.
- •Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
- •Subject had a history of allergic to statins
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