Comparative bioequivalence study of Azithromycin 250 mg Tablet of Cosar Pharmaceutical Co. and Zithromax® of Pfizer as reference in 24 healthy male under fasting condition

Cosar Pharmaceutical Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年10月16日

适应症

试验速览

暂无简介。

•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 that have normal vital signs.
•Subjects who agree with patient consent form.

•Known sensitivity to the tested products, hypertension (blood pressure in the standing position after at least 5 minutes of rest, systolic blood pressure greater than or equal to 140 mmHg, and diastolic blood pressure greater than or equal to 90 mmHg).
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•loss of more than 500 milliliters of blood in less than 7 days prior to testing.
•Subjects with significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.

发起方

Cosar Pharmaceutical Co.