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

Sobhan Darou Pharm. Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2020年3月24日

试验速览

暂无简介。

•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

•Subject showed clinically relevant deviations from normal in physical examination (BMI less than 18 or mor than 25, ... )
•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

发起方

Sobhan Darou Pharm. Co.