Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co.,Ltd.

Main research objectives: 1) To quantitatively analyze the total radioactivity in excreta after a single intravenous infusion of [14C] levonidazole disodium phosphate in healthy male subjects, and semi-quantitatively estimate the 14CO2 radioactive recovery rate in exhaled air, and obtain the human radioactive recovery rate data and the main excretion pathway; 2) To analyze the radioactive metabolite spectrum of human plasma, urine and feces after a single intravenous infusion of [14C] levonidazole disodium phosphate in healthy male subjects, identify the main metabolites, and determine the metabolic pathways and elimination pathways of levonidazole disodium phosphate in the human body; 3) To quantitatively analyze the total radioactivity in whole blood and plasma after a single intravenous infusion of [14C] levonidazole disodium phosphate in healthy male subjects, obtain the pharmacokinetic parameters of total plasma radioactivity, and investigate the distribution of total radioactivity in whole blood and plasma. Secondary study objectives: 1) To quantitatively analyze the concentration of levonidazole and other metabolites (if applicable) in plasma using a validated LC-MS/MS method and obtain the pharmacokinetic parameters of levonidazole and other metabolites (if applicable) in plasma; 2) To observe the safety of [14C] levonidazole disodium phosphate in healthy male subjects after a single dose.

To evaluate the efficacy and safety of nalbuphine hydrochloride injection in the treatment of moderate to severe postoperative pain by intravenous patient-controlled analgesia, using morphine hydrochloride injection as a positive control.

To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.