[Translation] A randomized, open-label, single-dose, two-period, self-crossover fasting and fed bioequivalence study of oseltamivir phosphate granules in healthy subjects
主要目的:以湖北康源药业有限公司研制的磷酸奥司他韦颗粒(规格:30 mg)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] Main purpose: Taking oseltamivir phosphate granules (specification: 30 mg) developed by Hubei Kangyuan Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence studies, it will be compared with oseltamivir phosphate produced by Chugai Pharmaceutical Co., Ltd. Compare the relative bioavailability of seltavir dry syrup (reference preparation, trade name: TAMIFLU®, specification: 3%, 30 mg/g) in healthy humans to examine the human bioequivalence of the two preparations.
Secondary 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.