Comparative bioequivalence study of Desloratadine 5 mg Tablet of ActoverCo. and Aerius of Merk 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: 2024年6月24日

试验速览

暂无简介。

•Healthy subjects (male) should be between 20-45 years old.
•subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2)
•Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination.
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•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.
•Subjects who has used any prescription or OTC drugs 14 days prior to the initiation of study and unable to refrain from the concomitant medications.
•History of alcohol or drug abuse.
•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.