[Translation] SAL0120: A single-center, non-randomized, open-label, single-dose, single-oral-administration material balance study in healthy adult male participants in China.
主要目的:
(1)定量分析健康男性研究参与者单次口服SAL0120后排泄物中的 总放射性量,获得人体放射性回收率数据和主要排泄途径
(2)获得健康男性研究参与者单次口服SAL0120后血浆、尿液和粪 便中的放射性代谢物谱,确定主要生物转化途径和主要代谢产物;
(3)量分析健康男性研究参与者单次口服SAL0120后全血和血浆 中的总放射性。
次要目的:
(1)定量分析血浆中SAL0120-I及其他代 谢产物(如适用)的浓度,获得血浆中SAL0120-I及其他代谢产物(如适 用)的药动学参数;
(2)观察健康男性研究参与者单次口服SAL0120后的安全性。
[Translation] Primary Objectives:
(1) To quantitatively analyze the total radioactivity in the excrement of healthy male study participants after a single oral dose of SAL0120, and to obtain data on human radioactivity recovery rate and main excretion routes.
(2) To obtain the radioactive metabolite profiles in plasma, urine, and feces of healthy male study participants after a single oral dose of SAL0120, and to determine the main biotransformation pathways and main metabolites.
(3) To quantitatively analyze the total radioactivity in whole blood and plasma of healthy male study participants after a single oral dose of SAL0120.
Secondary Objectives:
(1) To quantitatively analyze the concentrations of SAL0120-I and other metabolites (if applicable) in plasma, and to obtain pharmacokinetic parameters of SAL0120-I and other metabolites (if applicable) in plasma.
(2) To observe the safety of healthy male study participants after a single oral dose of SAL0120.