Randomized, single-dose, crossover comparative bioequivalence study of Eplerenone 50 mg tablet of ACTOVERCO and Pfizer Inc. in 24 healthy male under fasting conditions

ACtover 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3月6日

适应症

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 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.
•Subjects who agree with patient consent form.

•Subject has a history of significant renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder.
•Subjects with known allergy to the products tested.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•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.