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Study on PK of Hydronidone in Patients and Special Population

NCT04123769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-03-24

No results posted yet for this study

Summary

1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction).
2. To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.

Conditions

  • Hepatitis b & Liver Dysfunction

Interventions

DRUG

Hydronidone

First take Hydronidone capsule, single-dose and then Multiple-dose

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2020-10-09
Completion
2021-01-30

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 NCT04123769 on ClinicalTrials.gov