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临床试验/IRCT20190706044111N9
IRCT20190706044111N9已完成未知

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Rosuvastatin 20 mg tablet of Aburaihan Pharm Co., IRAN and Crestor 20 mg tablet of Astra-Zeneca in 24 healthy adult subjects under fasting condition

Aburaihan Pharm Co.0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

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

研究者

发起方
Aburaihan Pharm Co.

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