[Translation] A single-center, open, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of oseltamivir phosphate capsules in healthy subjects under fasting and fed conditions
主要目的:
比较空腹及餐后给药条件下,四川梓橦宫药业股份有限公司生产的磷酸奥司他韦胶囊(75mg/粒)与Roche Pharma (Schweiz) AG 持证的磷酸奥司他韦胶囊(75mg/粒,商品名:达菲®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:
评价空腹及餐后给药条件下,四川梓橦宫药业股份有限公司生产的磷酸奥司他韦胶囊(75mg/粒)与参比制剂达菲®(75mg/粒)的安全性。
[Translation] Primary objective:
To compare the differences in the extent and rate of absorption of oseltamivir phosphate capsules (75 mg/capsule) produced by Sichuan Ziligong Pharmaceutical Co., Ltd. and oseltamivir phosphate capsules (75 mg/capsule, trade name: Tamiflu®) certified by Roche Pharma (Schweiz) AG in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective:
To evaluate the safety of oseltamivir phosphate capsules (75 mg/capsule) produced by Sichuan Ziligong Pharmaceutical Co., Ltd. and the reference preparation Tamiflu® (75 mg/capsule) under fasting and postprandial administration conditions.