[Translation] Single center, randomized, open, single dose, two preparations, two cycles, two sequence crossover design of oseltamivir phosphate dry suspension in Chinese healthy subjects, divided into fasting administration and postprandial administration, human biology, etc. Efficacy study in two parts
本试验旨在研究单次空腹和餐后口服北京斯利安药业有限公司生产的磷酸奥司他韦干混悬剂〔6 mg/mL(以奥司他韦计)〕的药代动力学特征;以Roche Pharma AG生产的磷酸奥司他韦干混悬剂〔TAMIFLU®,6 mg/mL(以奥司他韦计)〕为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of oseltamivir phosphate dry suspension [6 mg/mL (calculated as oseltamivir)] produced by Beijing Silian Pharmaceutical Co., Ltd. ; Taking oseltamivir phosphate dry suspension [TAMIFLU®, 6 mg/mL (calculated as oseltamivir)] produced by Roche Pharma AG as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-t of the two preparations were compared , AUC0-∞, to evaluate the human bioequivalence of the two preparations.