[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence prediction of morphine sulfate extended-release tablets (30 mg/tablet) under fasting and postprandial dosing conditions in adult subjects with mild to moderate chronic pain pilot clinical research
主要研究目的:按有关生物等效性预试验的规定,选择持证商为Napp Pharmaceuticals Limited的硫酸吗啡缓释片(规格:30mg)为参比制剂,对威海路坦制药有限公司生产的受试制剂硫酸吗啡缓释片(规格:30mg)进行空腹和餐后给药人体生物等效性预试验,估算空腹和餐后给药后硫酸吗啡的药代动力学特征,为正式试验的设计提供一定的参考依据。
次要研究目的:观察轻、中度慢性疼痛成年受试者口服受试制剂硫酸吗啡缓释片(规格:30mg)和参比制剂硫酸吗啡缓释片(规格:30mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of the pre-test of bioequivalence, morphine sulfate sustained-release tablets (specification: 30mg) whose licensee is Napp Pharmaceuticals Limited is selected as the reference preparation, and the test sample produced by Weihailutan Pharmaceutical Co., Ltd. is selected as the reference preparation. Preparation Morphine Sulfate Sustained-Release Tablets (specification: 30mg) are pre-tested for human bioequivalence after fasting and postprandial administration, and the pharmacokinetic characteristics of morphine sulfate after fasting and postprandial administration are estimated to provide certain conditions for the design of formal trials. reference basis.
Secondary research objectives: To observe the safety of the test preparation morphine sulfate sustained-release tablets (specification: 30mg) and the reference preparation morphine sulfate sustained-release tablets (specification: 30mg) in adult subjects with mild to moderate chronic pain orally.