Comparative bioequivalence study of Valsartan 160 mg tablet of Karen Pharma and Food Supplement Co. and Novartis pharmaceuticals.

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1月11日

适应症

试验速览

暂无简介。

•Healthy candidates should be between 18-40 years old and their BMI should be in the range (Kg/m2) 18.5-30.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
•Subjects must have normal vital signs. Sitting systolic blood pressure is in the range of 110-120 mm Hg and diastolic blood pressure is in the range of 70-80 mm Hg and heart rate is 60-90 beats per minute.
•Subjects who agree with patient consent form.

•History of known allergies to valsartan, new drugs or any of the inactive components of the formulation;
•A history of liver or gastrointestinal disease that may interfere with the absorption, distribution, metabolism, or excretion of the drug;
•History of liver or kidney disease
•Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study period.
•History of anaphylaxis or angioedema
•History of bleeding or coagulation problems
•People who have taken over-the-counter or prescription drugs 7 days before the start of the first period will need to take the drug at the same time during the study.
•People with a history of alcohol or drug addiction
•Subjects who consume heavy caffeinated beverages, fruit juices (grapefruit juice) either follow a special diet (vegetarian) or do strenuous physical activity.
•History of difficulty donating blood or donating more than 500 ml of blood in less than seven days before the start of the study.

发起方

Karen Pharma and Food Supplement Co.