Bioequivalence study of ?Linagliptin 5 mg Tablet of Dorsa Pharmaceutical Co. and Trajenta of Boehringer as reference in 24 healthy male under fasting.

Dorsa Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) 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.

•Known hypersensitivity or idiosyncratic reaction to Linagliptin or inactive ingredients.
•Acute infection within one week preceding first study drug administration. Subject has a history of severe diseases which have direct impact on the study.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Subjects who have 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.
•Subjects who have a history of alcohol or substance abuse within the last 5 years.
•Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•Subject intends to be hospitalized within 3 months after first study drug administration.
•Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days.

发起方

Dorsa Pharmaceutical Co.