[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of oseltamivir phosphate dry suspension in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂磷酸奥司他韦干混悬剂(生产厂家:葵花药业集团(衡水)得菲尔有限公司)与参比制剂磷酸奥司他韦干混悬剂(持证商:Roche Registration GmbH,商品名:Tamiflu
®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂磷酸奥司他韦干混悬剂和参比制剂磷酸奥司他韦干混悬剂在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation oseltamivir phosphate dry suspension (manufacturer: Sunflower Pharmaceutical Group (Hengshui) Defei Co., Ltd.) and the reference preparation oseltamivir phosphate dry suspension (certificate holder: Roche Registration GmbH, trade name: Tamiflu
®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation oseltamivir phosphate dry suspension and the reference preparation oseltamivir phosphate dry suspension in healthy subjects.