[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of oseltamivir phosphate granules in healthy adult Chinese subjects
主要研究目的:
考察单次单剂量口服(空腹/餐后)75mg受试制剂磷酸奥司他韦颗粒【规格:0.9 g(按C16H28N2O4计),重庆万霖生物医药科技有限公司持有】与参比制剂磷酸奧司他韦干糖浆【Tamiflu®,规格:0.9 g,中外製薬株式会社持证】,在中国成年健康受试者体内的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main research purposes:
Examine a single oral dose (fasting/after meals) of 75 mg test preparation Oseltamivir Phosphate Granules [Specification: 0.9 g (calculated as C16H28N2O4), owned by Chongqing Wanlin Biomedical Technology Co., Ltd.] and the reference preparation Oseltamivir Phosphate Relative bioavailability of seltavir dry syrup [Tamiflu®, specification: 0.9 g, certified by Chugai Co., Ltd.] in Chinese adult healthy subjects. Analyze the pharmacokinetic parameters of the two preparations and evaluate the two preparations. The bioequivalence of the preparation provides a reference basis for the application and clinical use of the drug.
Secondary research purpose:
To evaluate the safety of single oral administration of the test preparation and reference preparation on an empty stomach or after a meal in Chinese adult healthy subjects.