Comparative bioequivalence study of Mirtazapine 15 mg Tablet of Actoverco. and Mirtazapina NORMON of NORMON 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: 2022年8月29日

试验速览

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•Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
•Subjects that have normal vital signs.
•Subjects who agree with patient consent form.

•Hypersensitivity to mirtazapine or related drugs.
•Taking any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing;
•Clinically significant illness during the 4 weeks prior to Period I dosing;
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period;
•History of alcohol or drug abuse within 2 years before the start of the study.
•Heavy drinker of caffeine, 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 500 ml blood within 7 days prior to the start of the study.

发起方

Actover Pharmaceutical Co.