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

Tolidaru Pharmaceutical Company0 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 with BMI less than 18 or more than 30
•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 two 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

Tolidaru Pharmaceutical Company