Randomized, single-dose, crossover comparative bioequivalence study of Metoprolol succinate 95 mg ER tablets of Actoverco and Recordati Pharma GmbH 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: 2021年11月1日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 40 years of age and Body Mass Index (BMI) between 18.5-30 (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 Metoprolol succinate or inactive ingredients.
•History or current bronchial asthma.
•Subjects who has used any drug including prescription drugs (within 14 days) or Over-The-Counter (OTC) drugs within 7 days prior to the start of the study and might need drug intake during study period;
•History of alcohol or drug abuse
•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.