[Translation] Randomized, open, single-dose, double-period, self-crossover fasting and postprandial bioequivalence trials of oseltamivir phosphate granules in healthy subjects
主要研究目的:以成都第一制药有限公司研制的磷酸奥司他韦颗粒(规格:0.9 g(按C16H28N2O4计))为受试制剂,按生物等效性研究的有关规定,与中外製薬株式会社生产的磷酸奥司他韦干糖浆(参比制剂,商品名:TAMIFLU®,规格:3%,30 mg/g)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要研究目的:观察受试制剂磷酸奥司他韦颗粒和参比制剂磷酸奥司他韦干糖浆(商品名:TAMIFLU®)在健康受试者中的安全性。
[Translation] The main purpose of the study: Taking oseltamivir phosphate granules (specification: 0.9 g (calculated as C16H28N2O4)) developed by Chengdu First Pharmaceutical Co., Ltd. The produced oseltamivir phosphate dry syrup (reference preparation, trade name: TAMIFLU®, specification: 3%, 30 mg/g) was compared with the relative bioavailability in healthy humans, and the human bioequivalence of the two preparations was investigated .
Secondary research purpose: To observe the safety of the test preparation oseltamivir phosphate granules and the reference preparation oseltamivir phosphate dry syrup (trade name: TAMIFLU®) in healthy subjects.