[Translation] Bioequivalence trial of oseltamivir phosphate capsules in healthy subjects in a single-center, open-label, balanced, randomized, single-dose, double-cycle, double-crossover fasting and postprandial state
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] main purpose:
Comparison of Oseltamivir Phosphate Capsules (75mg/capsule) produced by Sichuan Zilugong Pharmaceutical Co., Ltd. and Oseltamivir Phosphate Capsules (75mg/capsule) licensed by Roche Pharma (Schweiz) AG under the conditions of fasting and postprandial administration. /capsule, trade name: Tamiflu®) in healthy adult population to evaluate its bioequivalence based on differences in the extent and rate of absorption.
Secondary purpose:
To evaluate the safety of oseltamivir phosphate capsules (75mg/capsule) produced by Sichuan Zilugong Pharmaceutical Co., Ltd. and the reference preparation Tamiflu® (75mg/capsule) under the conditions of fasting and postprandial administration.