Randomized, single-dose, crossover comparative bioequivalence study of Linagliptin 5 mg tablets of Alhavi pharmaceutical co. and Boehringer in 24 healthy male under fasting conditions

Alhavi pharmaceutical co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2020年8月17日

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 ECG and vital signs.
•Subjects who agree with patient consent form.

•Known hypersensitivity to linagliptin or inactive ingredients
•Acute and chronic cardiovascular, respiratory, gastrointestinal diseases, neuroendocrine disorders, blood system disorders and renal or hepatic impairment
•Acute infectious diseases less than 1 weeks prior to the start of the study
•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
•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
•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

Alhavi pharmaceutical co.