Randomized, single-dose, crossover comparative bioequivalence study of Escitalopram 10 mg film-coated tablets of Actoverco. and Lundbeck Limited Co. in 18 healthy male under fasting conditions

Actover pharmaceutical co.0 个研究点目标入组 18 人开始时间: 待定最近更新: 2021年2月22日

试验速览

暂无简介。

•Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5-30 (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 or idiosyncratic reaction to Escitalopram or inactive Allergy to any medication, substance, or food.
•History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, any kind of anemia, asthma, and mental disease.
•Muscular trauma 21 days before the beginning of the study.
•Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning 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

发起方

Actover pharmaceutical co.