[Translation] A single-center, open-label, single-dose clinical trial evaluating the in vivo absorption, metabolism, and excretion of [14C]ZG-001 capsules in healthy male participants.
主要目的:
定量分析健康男性参与者口服[14C] ZG-001 胶囊后排泄物(尿液和粪便)中总放射性,获得人体内放射性回收率数据,确定主要排泄途径;测定健康男性参与者口服[14C] ZG-001 胶囊后血浆、尿液和粪便中的放射性代谢物谱并鉴定主要代谢产物,提供ZG-001 在人体内的主要代谢途径数据,确定主要生物转化途径;考察[14C]ZG-001 在健康男性参与者全血和血浆中总放射性的药代动力学特征,并考察全血和血浆中总放射性的分配情况。
次要目的:
定量分析血浆中 ZG-001 原形药物及代谢产物 ZG-001-M3的浓度,获得血浆中相应分析物的药代动力学参数;观察单剂量口服[14C] ZG-001 胶囊后参与者的安全性。
[Translation] Primary Objectives: To quantitatively analyze the total radioactivity in excrement (urine and feces) of healthy male participants after oral administration of [14C] ZG-001 capsules, obtain data on radioactivity recovery in the human body, and determine the main excretion pathway; to determine the radiometabolite profiles in plasma, urine, and feces of healthy male participants after oral administration of [14C] ZG-001 capsules and identify the main metabolites, providing data on the main metabolic pathways of ZG-001 in the human body and determining the main biotransformation pathways; to investigate the pharmacokinetic characteristics of total radioactivity of [14C] ZG-001 in whole blood and plasma of healthy male participants, and to investigate the distribution of total radioactivity in whole blood and plasma.
Secondary Objectives: To quantitatively analyze the concentrations of parent ZG-001 and its metabolite ZG-001-M3 in plasma, obtain the pharmacokinetic parameters of the corresponding analytes in plasma; to observe the safety of participants after a single oral dose of [14C] ZG-001 capsules.