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Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects

NCT05711797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-11-05

No results posted yet for this study

Summary

The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects.

The main questions it aims to answer are:

* Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex.
* To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.

Conditions

  • Influenza, Human

Interventions

DRUG

ZX-7101A 80mg

ZX-7101A a drug to treatment influenza in Chinese adults

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Xian yu huang, doctor · Huashan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2024-02-06
Completion
2024-08-09

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 NCT05711797 on ClinicalTrials.gov