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Overview

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation, oseltamivir phosphate granules (strength: 0.9 g), and the reference formulation, oseltamivir phosphate dry syrup (Tamiflu®, strength: 3% (30 g)) in healthy adult participants under fasting conditions

主要研究目的：评估空腹状态下单次口服受试制剂磷酸奥司他韦颗粒（规格：0.9 g，浙江国镜药业有限公司持证）和参比制剂磷酸奥司他韦干糖浆（Tamiflu®，规格：3%（30 g），中外製薬株式会社持证）在健康参与者中的生物等效性。次要研究目的：评估受试制剂磷酸奥司他韦颗粒（规格：0.9 g）和参比制剂磷酸奥司他韦干糖浆（Tamiflu®，规格：3%（30 g））在健康参与者中的安全性。

[Translation]

The main purpose of the study is to evaluate the bioequivalence of a single oral dose of the test preparation oseltamivir phosphate granules (specification: 0.9 g, certified by Zhejiang Guojing Pharmaceutical Co., Ltd.) and the reference preparation oseltamivir phosphate dry syrup (Tamiflu®, specification: 3% (30 g), certified by Chugai Pharmaceutical Co., Ltd.) in healthy participants under fasting conditions. Secondary study objective: To evaluate the safety of the test formulation, oseltamivir phosphate granules (strength: 0.9 g) and the reference formulation, oseltamivir phosphate dry syrup (Tamiflu®, strength: 3% (30 g)) in healthy participants.

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Zhejiang Guojing Pharmaceutical Co., Ltd.

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