Overview

Study on Human Mass Balance of SPH3127 Tablets

Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd