Comparative bioequivalence study of Sacubitril 97 mg+ Valsartan 103 mg mg F.C. Tablet of Zist Arvand Pharmed. and Entresto®of Novartis as reference in 24 healthy male under fasting condition

Zist Arvand Pharme Ltd.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age.
•Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 27 (inclusive), calculated as kg/m2.
•General laboratory tests of biochemistry, hematology, TSH, HIV, HBs and HCV are performed.
•Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination.
•Subjects with normal vital signs.

•Subjects with known allergy to the products tested.
•volunteers with associated acute or chronic infections;
•blood pressure in standing position and after at least 5 minutes of rest, systole less than 90 or more than 140 mmHg and diastole less than 50 or more than 90 mmHg);
•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 per day and could not tolerate cigarette cessation during each clinical period;
•A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study;

发起方

Zist Arvand Pharme Ltd.