Shaanxi Jiuzhou (Group) Pharmaceutical Industry Co.

Main purpose: Using the acetaminophen and dihydrocodeine tablets (trade name: Co-dydramol®, specifications: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) produced by Accord UK Ltd as the reference preparation, and the acetaminophen and dihydrocodeine tablets (specifications: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) developed and produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-period, crossover trial design was used to evaluate the bioequivalence of the two preparations in healthy subjects in the fasting and postprandial state after a single oral administration. Secondary purpose: Observe and evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Using the Paracetamol and Dihydrocodeine Tablets (trade name: Co-dydramol®, specifications: 500 mg paracetamol and 10 mg dihydrocodeine tartrate) produced by Accord UK Ltd as the reference preparation and the Paracetamol and Dihydrocodeine Tablets (specifications: 500 mg paracetamol and 10 mg dihydrocodeine tartrate) developed and produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-period, crossover study was conducted to evaluate the bioequivalence of the two preparations after single oral administration in healthy subjects under fasting and fed conditions.

Primary objective: To evaluate the bioequivalence of the two preparations by using a single-center, randomized, open, single-dose, two-period, crossover design, using tramadol acetaminophen tablets (trade name: ULTRACET®, specifications: tramadol hydrochloride 37.5 mg, acetaminophen 325 mg) produced by Janssen Ortho, LLC. as the reference preparation and tramadol acetaminophen tablets (specifications: tramadol hydrochloride 37.5 mg, acetaminophen 325 mg) produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy adult subjects in China.