[Translation] A randomized, open-label, single-dose, two-period, self-crossover fasting and fed bioequivalence trial of oseltamivir phosphate granules in healthy study participants
主要研究目的:以湖南欧亚药业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®)在健康研究参与者中的安全性
[Translation] The main purpose of the study: To use oseltamivir phosphate granules (specification: 0.9 g (calculated as C16H28N2O4)) developed by Hunan Eurasia Pharmaceutical Co., Ltd. as the test preparation, and to compare the relative bioavailability in healthy humans with that of oseltamivir phosphate dry syrup (reference preparation, trade name: TAMIFLU®, specification: 3%, 30 mg/g) produced by Chugai Pharmaceutical Co., Ltd. in accordance with the relevant provisions of bioequivalence studies, and to investigate the human bioequivalence of the two preparations.
Secondary study objective: To observe the safety of the test formulation of oseltamivir phosphate granules and the reference formulation of oseltamivir phosphate dry syrup (trade name: TAMIFLU®) in healthy study participants