Weihai Lutan Pharmaceutical Co. Ltd.

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.

Main research purpose: According to the relevant provisions of the bioequivalence pre-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 by Weihai Lutan Pharmaceutical Co., Ltd. were conducted on the fasting and post-meal administration of human bioequivalence pre-tests, and the pharmacokinetic characteristics of morphine sulfate after fasting and post-meal administration were estimated, providing a certain reference basis for the design of the formal test. Secondary research purpose: 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) by adult subjects with mild and moderate chronic pain.

This is a non-inferiority trial, which evaluates the efficacy and safety of Weihailutan Morphine Sulfate Sustained-Release Tablets Lutai in the treatment of chronic pain by comparing it with the traditional analgesic drug MSContin Morphine Sulfate Sustained-Release Tablets.