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Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China

NCT05720091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-05

No results posted yet for this study

Summary

The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are:

* Quantitative analysis of total fecal and urine radioactivity in healthy subjects after oral administration of \[14C\]ZX-7101A to obtain human radioactive recovery data and main excretion routes.
* Pharmacokinetics of total activity in whole blood and plasma, and distribution of total activity in whole blood and plasma are quantitatively analyzed after oral administration of \[14C\]ZX-7101A in healthy subjects.
* Quantitative analysis of the radioactive metabolites in plasma, urine and feces of healthy subjects with once \[14C\]ZX-7101A orally administration, identification of the main metabolites of the radioactive metabolites (close to or greater than 10% of the total radioactive AUC in plasma), and determination of the main biotransformation and elimination pathway of ZX-7101A.

Conditions

  • Influenza, Human

Interventions

DRUG

ZX-7101A 80mg

a drug to treatment influenza in Chinese adults

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • liyan Miao, doctor · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-03-20
Completion
2023-07-25

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 NCT05720091 on ClinicalTrials.gov