Comparative bioequivalence study of Escitalopram 20 mg F.C. Tablet of Karen. and Cipralex of Lundbeck Limited as reference in 24 healthy male under fasting.

Karen Pharma and Food Supplement Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•Healthy subjects (male) between 18 – 40 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
•Sitting blood pressure less than 100/ 60 mm Hg;
•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.
•Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
•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 450 ml blood within 60 days prior to the start of the study.

发起方

Karen Pharma and Food Supplement Co.