FCN-437c 在肝功能损害受试者中的单剂量、平行、开放的药代动力学研究
[Translation] A single-dose, parallel, open-label pharmacokinetic study of FCN-437c in subjects with hepatic impairment
主要研究目的:评价并比较 FCN-437c 在轻度、中度肝功能损害受试者和健康受试者中 的药代动力学特征,为肝功能损害患者的临床用药提供依据
次要研究目的:评价轻度、中度肝功能损害受试者以及健康受试者服用 FCN-437c 的安全性
[Translation] Primary study objective: To evaluate and compare the pharmacokinetic characteristics of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment
Secondary study objective: To evaluate the safety of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects
一项单中心、随机、双盲、安慰剂对照设计评价健康受试者单次口服FCN-437c胶囊的药代动力学及对QT间期影响的I期临床研究
[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical study to evaluate the pharmacokinetics and effects of a single oral dose of FCN-437c capsules on the QT interval in healthy subjects
【主要研究目的】
通过C-QTc效应模型评价FCN-437c的血药浓度对QT间期的影响。
【次要研究目的】
1. 评价健康受试者单次口服300mg或400mg FCN-437c胶囊的安全性;
2. 评价健康受试者单次口服300mg或400mg FCN-437c胶囊,FCN-437c的药代动力学特征。
[Translation] [Main study objectives]
Evaluate the effect of FCN-437c blood concentration on QT interval by C-QTc effect model.
[Secondary study objectives]
1. Evaluate the safety of a single oral administration of 300mg or 400mg FCN-437c capsules to healthy subjects;
2. Evaluate the pharmacokinetic characteristics of FCN-437c after a single oral administration of 300mg or 400mg FCN-437c capsules to healthy subjects.
[14C]FCN-437c在健康受试者体内的物质平衡临床试验
[Translation] Clinical trial of [14C]FCN-437c in healthy subjects: a study of its substance balance
【主要研究目的】
1 定量分析男性健康受试者口服[14C]FCN-437c后,排泄物中的总放射性,获得人体放射性的累计排泄率和主要排泄途径;
2 考察男性健康受试者单次口服[14C]FCN-437c后,全血和血浆中的分配情况,血浆中总放射性的药代动力学;
3 鉴定男性健康受试者口服[14C]FCN-437c后,血浆、尿液、粪便中的主要代谢产物,确定主要生物转化途径和主要代谢产物;
4 采用已验证的LC-MS/MS方法定量分析血浆中FCN-437c及其主要代谢产物的浓度,获得血浆中FCN-437c及其主要代谢产物的药代动力学参数。
【次要研究目的】观察[14C]FCN-437c单次给药后男性健康受试者的安全性。
[Translation] [Main study objectives]
1 To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]FCN-437c to healthy male subjects, and obtain the cumulative excretion rate and main excretion pathway of human radioactivity;
2 To investigate the distribution of [14C]FCN-437c in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]FCN-437c to healthy male subjects;
3 To identify the main metabolites in plasma, urine and feces after oral administration of [14C]FCN-437c to healthy male subjects, and determine the main biotransformation pathways and main metabolites;
4 To quantitatively analyze the concentration of FCN-437c and its main metabolites in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of FCN-437c and its main metabolites in plasma.
[Secondary study objectives] To observe the safety of healthy male subjects after a single administration of [14C]FCN-437c.
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