Comparative bioequivalence study of Desloratadine 5 mg Tablet of Darou Darman Arang . and Aerius of Organon as reference in 24 healthy male under fasting.

Darou darman Arang0 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

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•Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 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.

•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

Darou darman Arang