Comparative bioequivalence study of fexofenadin 30 mg/5 ml suspension of . and Allegra of SANOFI as reference in 24 healthy male under fasting.

Darou darman Pars Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年3月13日

试验速览

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•Healthy subjects (male) between 18 – 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 fexofenadine or any inactive ingredients in the formulation.
•Any significant clinical disease or surgical procedure within 4 weeks prior to drug administration;
•Any significant clinical abnormality detected during screening;
•Abnormal vital signs during screening (Systolic blood pressure less than 90 or more than 140 mm Hg or diastolic blood pressure less than 50 mm Hg or more than 90 mm Hg or Pulse rate less than 50/minute or more than 100/minute).
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period;
•Subjects who has used any drug including Over-The-Counter (OTC) drugs within 7 days prior to the start of the study or prescription drugs (within 14 days) 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

Darou darman Pars Co.