Comparative bioequivalence study of Sitagliptin 100 mg tablet of Actoverco. and Januvia 100 mg tablet of Merck as reference in 24 healthy male under fasting.

Actover Pharmaceutical 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30日

试验速览

暂无简介。

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

•Hypersensitivity to the DPP-4 inhibitors, investigational drug and/or to inactive constituents.
•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, or caffeinated drinks.
•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.
•Heavy drinker of grapefruit juice
•Subjects on special diet (such as vegetarians)
•Subjects who do exertional physical activity.

发起方

Actover Pharmaceutical Co.