Comparative bioequivalence study of Ticagrelor 90 mg F.C. Tablet of Zist Arvand Pharmed. and Brilinta®of Asterazeneca Sciences 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3月6日

适应症

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.
•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.
•Personal history of vascular abnormality such as aneurysm, thrombocytopenia, peptic ulcer and platelet count less than 109*150/liter.
•heart rate less than 60 per minute.
•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.