Yangtze River Pharmaceutical Group Jiangsu Zilong Pharm

Primary Objective: To investigate the pharmacokinetic behavior of a single-dose buprenorphine transdermal patch (T, strength: 20 mg/patch (20 μg/h), Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co., Ltd.) compared to a reference formulation (R, trade name: BuTrans®, strength: 20 mg/patch (20 μg/h), Purdue Pharma L.P.) in healthy volunteers under the fasting state and to evaluate the bioequivalence of the two formulations. Secondary Objective: To evaluate the safety of the test buprenorphine transdermal patch and the reference formulation, BuTrans®, in healthy volunteers and to assess the adhesiveness of the two formulations.

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.