Comparative bioequivalence study of two different Pantoprazole 40mg formulations (Exir Pharmaceutical Company & reference) in 24 Iranian volunteers

Exir Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•24 healthy male and female volunteers will participate in this study
•Aged 18 to 45 years based on laboratory safety tests
•Paraclinical health based on tests performed
•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
•Adherence to the criteria on the basis of moral obligation and signed an informed consent
•Actual weight (TBW) in the range of 20% IBW

•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 alcohol abuse or smokes more than 10 cigarettes per day.
•Use any medication within 14 days before the first treatment.
•A history of allergic to biguanides

发起方

Exir Pharmaceutical Company