Weihai Lutan Pharmaceutical Co., Ltd.

Primary objective: In accordance with relevant bioequivalence testing regulations, acetaminophen/hydrocodone tablets (specification: acetaminophen 325mg/hydrocodone bitartrate 10mg) manufactured by Specgx LLC was selected as the reference formulation. Human bioequivalence studies were conducted on the test formulation (acetaminophen 325mg/hydrocodone bitartrate 10mg) manufactured and supplied by Weihai Lutan Pharmaceutical Co., Ltd., under both fasting and postprandial administration conditions. The differences in the absorption rate and extent of absorption of the drug in the test formulation and the reference formulation were compared to determine if they were within acceptable limits, thus evaluating the bioequivalence of the two formulations under fasting and postprandial administration conditions. Secondary objective: To observe the safety of participants after taking the test formulation and the reference formulation under both fasting and postprandial conditions.

The primary study objective was to conduct a bioequivalence study in humans using the reference preparation, Paracetamol and Dihydrocodeine Tablets (trade name: Co-dydramol; strength: 10 mg/500 mg), licensed by Accord UK Ltd, as the reference preparation in accordance with relevant bioequivalence testing regulations. The study compared the test preparation, Paracetamol and Dihydrocodeine Tablets (strength: 0.5 g paracetamol and 10 mg dihydrocodeine tartrate), produced and provided by Weihai Lutan Pharmaceutical Co., Ltd., under both fasting and fed conditions. The study compared the absorption rate and extent of the test preparation with those of the reference preparation to determine if they were within acceptable limits, and to evaluate the bioequivalence of the two preparations under fasting conditions. The secondary study objective was to investigate the safety of the test preparation, Paracetamol and Dihydrocodeine Tablets (strength: 0.5 g paracetamol and 10 mg dihydrocodeine tartrate), and the reference preparation, Paracetamol and Dihydrocodeine Tablets (trade name: Co-dydramol; strength: 10 mg/500 mg), in healthy Chinese volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, acetaminophen hydrocodone tablets (specification: acetaminophen 325mg/hydrocodone bitartrate 7.5mg) with the license holder Specgx Llc were selected as the reference preparation, and the test preparation acetaminophen hydrocodone tablets (specification: acetaminophen 325mg/hydrocodone bitartrate 7.5mg) produced and provided by Weihai Lutan Pharmaceutical Co., Ltd. were subjected to human bioequivalence test under fasting conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of the test preparation acetaminophen hydrocodone tablets and the reference preparation acetaminophen hydrocodone tablets after fasting in healthy Chinese subjects.