NCT05593562

Study on Human Mass Balance of SPH3127 Tablets

A Clinical Trial to Evaluate Absorption, Metabolism and Excretion of [14C]SPH3127 in Healthy Chinese Adult Male Subjects (Human Mass Balance and Biotransformation Study of [14C]SPH3127)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary Mild and Moderate Hypertension

Interventions

Type	Name	Description
DRUG	SPH3127	Oral 100 mg \[14 c\] SPH3127 mixed suspension

Timeline

• Start date: 2022-10-16
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2022-10-25
• Last updated: 2022-12-07

Locations

1 site across 1 country: China