Study on Human Mass Balance of SPH3127 Tablets

Summary

To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of \[14C\] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of \[14C\]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of \[14C\] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.

Timeline

Start

2022-10-16

Primary completion

2022-10-24

Completion

2022-10-24

Drugs

Indications