Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

Bioequivalence study of cefpodoxime proxetil tablets in healthy subjects

Main purpose: This study used the oseltamivir phosphate dry suspension (specification: 6 mg/mL) certified by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. as the test preparation and the oseltamivir phosphate dry suspension (trade name: Tamiflu, specification: 6 mg/mL) certified by Roche Registration GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

The purpose of this study was to study the pharmacokinetic characteristics of a single oral dose of cefdinir granules (50 mg/packet × 1 pack) developed and produced by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. after meals, and to compare the pharmacokinetic parameters of the two preparations with those of cefdinir fine granules (Cefzon®, 50 mg/packet × 1 pack) produced by LTL Pharmaceutical Co., Ltd. of Japan, and to evaluate the bioequivalence of the two preparations in humans.