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Study on Human Mass Balance of SPH3127 Tablets

NCT05593562 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-12-07

No results posted yet for this study

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

DRUG

SPH3127

Oral 100 mg \[14 c\] SPH3127 mixed suspension

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-16
Primary Completion
2022-10-24
Completion
2022-10-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05593562 on ClinicalTrials.gov