Zhejiang Zhongyi Pharmaceutical Co., Ltd.

A single-center, randomized, open, three-period, partially repeated crossover, single-dose design was used to compare the differences in absorption extent and rate between oxycodone acetaminophen tablets (specification: 325 mg acetaminophen/5 mg oxycodone hydrochloride) produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd. and oxycodone acetaminophen tablets (trade name: PERCOCET®, specification: 325 mg acetaminophen/5 mg oxycodone hydrochloride) produced by VINTAGE PHARMACEUTICALS LLC under fasting and postprandial administration in healthy Chinese people, and to evaluate the safety of oxycodone acetaminophen tablets (specification: 325 mg acetaminophen/5 mg oxycodone hydrochloride) produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.

The pilot study was conducted in a small number of volunteers, using a single-center, randomized, open, two-period crossover, single-dose, postprandial administration design. The pharmacokinetic parameters of erythromycin enteric-coated capsules (specification: 250 mg) produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd. and erythromycin enteric-coated capsules (trade name: ERYC®, specification: 250 mg) certified by Mayne Pharma International Pty Ltd were compared. The possibility of bioequivalence of the two preparations under postprandial conditions was preliminarily evaluated, which provided a basis for the design of blood collection points and washout periods in the formal bioequivalence study protocol, and the safety of erythromycin enteric-coated capsules in healthy subjects was observed.

This study aimed to study the pharmacokinetic characteristics of azithromycin enteric-coated capsules (0.25 g) developed and produced by Zhejiang Huarun Sanjiu Zhongyi Pharmaceutical Co., Ltd. after a single oral administration after meal; using azithromycin tablets (Zithromax®, 0.25 g) produced by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to provide a reference for the formal trial.