Weihai Lutan Pharmaceutical Co., Ltd.

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.

The main purpose of the study: According to the relevant provisions of the bioequivalence test, the morphine sulfate sustained-release tablets (specification: 30 mg) of the licensee Napp Pharmaceuticals Limited were selected as the reference preparation, and the test preparation morphine sulfate sustained-release tablets (specification: 30 mg) produced and provided by Weihai Lutan Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence tests 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 and postprandial administration conditions. Secondary study objectives: To observe the safety of oral administration of the test preparation morphine sulfate sustained-release tablets (specification: 30 mg) and the reference preparation morphine sulfate sustained-release tablets (specification: 30 mg) in adult subjects with mild and moderate chronic pain.