[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design, fasting/fed bioequivalence study of oseltamivir phosphate dry suspension in healthy subjects
本试验旨在研究单次空腹和餐后口服四川子仁制药有限公司研制、生产的磷酸奥司他韦干混悬剂〔6 mg/mL(以奥司他韦计),包装规格:360 mg/瓶*1瓶/盒〕的药代动力学特征;以F. Hoffmann-La Roche AG生产的磷酸奥司他韦干混悬剂〔TAMIFLU®,6 mg/mL(以奥司他韦计),包装规格:360 mg/瓶*1瓶/盒〕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] This study aimed to study the pharmacokinetic characteristics of a single fasting and postprandial oral administration of an oseltamivir phosphate dry suspension [6 mg/mL (as oseltamivir), packaging specification: 360 mg/bottle*1 bottle/box] developed and produced by Sichuan Ziren Pharmaceutical Co., Ltd.; using an oseltamivir phosphate dry suspension [TAMIFLU®, 6 mg/mL (as oseltamivir), packaging specification: 360 mg/bottle*1 bottle/box] produced by F. Hoffmann-La Roche AG as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.