Comparative bioequivalence study of Mesalazine 500 mg ER Capsule of Karen. and PENTASA®of Ferring as reference in 24 healthy male under fasting condition

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6月26日

适应症

试验速览

暂无简介。

•Healthy subjects (male) between 20 – 45 years of age
•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 normal vital signs.
•Subjects who agree with patient consent form.

•Subjects with clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations
•Subjects with known allergy to the products tested or NSAIDs.
•Significant clinical illness within 3 weeks prior to screening.
•History of GI surgery or any other surgery within the past 3 months.
•History of any significant disease that jeopardize safety of the subject or validity of test results.
•History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical 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.