Comparative bioequivalence study of ?Apixaban 5 mg Tablet of Actoverco. and Eliquis of Pfizer 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: 2023年2月7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 the 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
•PT (prothrombin time) and aPTT (activated partial prothrombin time) within the normal range
•Subjects who agree with a patient consent form

•Subjects with known allergies to the products tested
•Creatinine Clearance (CrCl) of more than 50
•Consumption of caffeine-containing products from 24 hours before dosing till 24 hours after its administration
•Any clinically significant illness during the 4 weeks prior to the first study drug administration
•Hypotension (systolic blood pressure =100 mmHg or diastolic blood pressure =65 mmHg) or hypertension (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg)
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period
•Recent use of concomitant medication (prescription or over-the-counter) that could increase the risk of bleeding, or influence apixaban pharmacokinetics
•History of alcohol or drug abuse
•Heavy drinkers of caffeine, grapefruit juice, or caffeinated drinks or who are on a 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

Actover Pharmaceutical Co.