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.

The preliminary study compared the pharmacokinetic parameters of the test preparation and the reference preparation, evaluated the possibility of bioequivalence under postprandial conditions, provided a basis for the design of the formal bioequivalence study, and observed the safety of erythromycin enteric-coated capsules in healthy subjects. The formal study compared the differences in absorption between the test preparation and the reference preparation in healthy Chinese people, and evaluated the safety of erythromycin enteric-coated capsules produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.