Comparative bioequivalence study of Metformin 1000 mg E.R. Tablet of Dorsa Pharmaceutical Co and Merck

Dorsa Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年6月24日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.

•History of known sensitivity to the tested products
•Associated acute or chronic infections
•Blood pressure in standing position and after 5 minutes of rest, systole less than 90 or more than 140 mm Hg and diastole less than 50 or more than 90 mm Hg.
•Heart rate less than 50 or more than 90 beats per minute
•Abnormalities in ECG include (PR > 210 msec, QRS complex > 120 msec, QTcF > 430 msec)
•Smoking more than 10 cigarettes a day
•Loss of more than 500 ml of blood in less than 7 days.

发起方

Dorsa Pharmaceutical Co.