Hebei Aoxing Group Pharmaceutical Co. Ltd.

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.

This study used NoDoz Alertness Aid Maximum Strength, a caffeine tablet produced by Lil' Drug Store Products, Inc., as the reference preparation to evaluate the pharmacokinetics and bioequivalence of a single oral dose of caffeine tablets produced by Hebei Aoxing Group Pharmaceutical Co., Ltd. in healthy adult subjects.