Comparative bioequivalence study of Sodium Valproate 500 mg ER Tablet of Abian Pharmed and SANOFI Inc. in 24 healthy male under fasting conditions

Abian Pharmed Co.0 个研究点目标入组 26 人开始时间: 待定最近更新: 2021年11月29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 according to the accepted normal values 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.

•Subjects with known allergy to the products tested.
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
•Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
•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 within 2 years before the start of the study;
•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

Abian Pharmed Co.