Comparative bioequivalence study of Rosuvastatin 40 mg tablets of Karen Pharma and Food Supplement Co. and Apotex Inc. in 24 healthy male under fasting.

Karen Pharma and Food Supplement Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年5月2日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) 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.
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•Known hypersensitivity or idiosyncratic reaction to Rosuvastatin or inactive ingredients.
•History or existence of hepatic or GI diseases or any other condition that could interfere with the absorption, distribution, excretion or metabolism of the drug.
•Current or chronic history of liver disease, or know hepatic or biliary abnormalities.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
•History of alcohol or drug abuse.
•Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•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

Karen Pharma and Food Supplement Co.