/ Not yet recruitingNot Applicable 磷酸奥司他韦胶囊在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence bioequivalence study of oseltamivir phosphate capsules in healthy subjects under fasting and fed conditions
主要目的:以海南赛科药业有限公司提供的磷酸奥司他韦胶囊为受试制剂,按生物等效性试验的有关规定,与Roche Pharma(Schweiz)AG持有,Delpharm Milano S.r.l.生产的磷酸奥司他韦胶囊(商品名:Tamiflu®/达菲®,参比制剂)对比在健康人体内的吸收速度及吸收程度,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胶囊和参比制剂磷酸奥司他韦胶囊(商品名:Tamiflu®/达菲®)在健康受试者中的安全性。
[Translation] Main purpose: Using oseltamivir phosphate capsules provided by Hainan Saike Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of oseltamivir phosphate capsules (trade name: Tamiflu®/Tamiflu®, reference preparation) owned by Roche Pharma (Schweiz) AG and produced by Delpharm Milano S.r.l. were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation oseltamivir phosphate capsules and the reference preparation oseltamivir phosphate capsules (trade name: Tamiflu®/Tamiflu®) in healthy subjects.
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