Hebei Aoxing Group Pharmaceutical Co. Ltd.

(1) To compare the pharmacokinetic characteristics of the test drug and the control drug after single and multiple oral administration of tilidine hydrochloride compound sustained-release tablets in healthy adult participants; (2) To evaluate the effect of food on the pharmacokinetics of tilidine hydrochloride compound sustained-release tablets in healthy adult participants after single oral administration; (3) To evaluate the safety of tilidine hydrochloride compound sustained-release tablets in healthy adult participants after single and multiple oral administration.

Primary objective: This study used oxycodone acetaminophen tablets (specifications: 5 mg oxycodone hydrochloride and 325 mg acetaminophen) produced by Hebei Aoxing Group Pharmaceutical Co., Ltd. as the test preparation and oxycodone acetaminophen tablets (trade name: PERCOCET®, specifications: 5 mg oxycodone hydrochloride and 325 mg acetaminophen) produced by Par Pharmaceutical, a licensed company of Endo Pharmaceuticals Inc., as the reference preparation to evaluate the bioequivalence of the two preparations when taken orally under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation and reference preparation of oxycodone acetaminophen tablets in healthy humans.

Main purpose This study used oxycodone acetaminophen tablets (specification: oxycodone hydrochloride 5mg/acetaminophen 325mg) produced by Hebei Aoxing Group Pharmaceutical Co., Ltd. as the test preparation, and oxycodone acetaminophen tablets (trade name: PERCOCET, specification: oxycodone hydrochloride 5mg/acetaminophen 325mg) produced by Endo Pharmaceuticals Inc. with a license Par Pharmaceutical as the reference preparation to observe the in vivo kinetics of oxycodone and acetaminophen after oral administration of oxycodone acetaminophen tablets to Chinese healthy subjects after a meal, and to estimate the corresponding pharmacokinetic parameters. Secondary purpose To observe the safety of the test preparation and reference preparation of oxycodone acetaminophen tablets in healthy humans.