Shanghai Fushang Huichuang Pharmaceutical Research Co Ltd

[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.

[Main study objective] Effect of high-fat diet on the pharmacokinetics of FCN-437c capsules in healthy Chinese adult subjects. [Secondary study objective] To evaluate the safety of FCN-437c capsules in healthy subjects in fasting and fed states.

Main purpose: To evaluate the effects of itraconazole capsules and rifampicin capsules on the main pharmacokinetic parameters of FCN-437c after oral administration of FCN-437c capsules to Chinese healthy subjects Secondary purpose: 1) To evaluate the effects of itraconazole capsules and rifampicin capsules on other pharmacokinetic parameters of FCN-437c after oral administration of FCN-437c capsules to Chinese healthy subjects 2) To evaluate the safety of single-dose oral administration of FCN-437c capsules and its combination with itraconazole capsules and rifampicin capsules in Chinese healthy subjects