Comparative bioequivalence study of Amlodipine10/Valsartan160 Tablet of Karen Pharma and Food Supplement Co. and EXFORGE® of Novartis as reference 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: 2023年2月7日

试验速览

暂无简介。

•Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range (kg/m2) 18.5 and 30.
•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.

•Subjects with known allergy to the products tested.
•Acute infection within one week preceding first study drug administration.
•Hypotension (systolic blood pressure =100 mmHg or diastolic blood pressure =65 mmHg) or hypertension (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg)
•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 caffeine, 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.