Study on PK of Hydronidone in Patients and Special Population

Hepatitis b & Liver Dysfunction Clinical Trial

Official title: Pharmacokinetics of Hydronidone Capsules in Patients With Chronic Hepatitis B Complicated With Liver Fibrosis and Mild Hepatic Insufficiency

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis b & Liver Dysfunction
• Liver Diseases

• NCT number: NCT04123769
• Study type: Interventional
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2019
• Completion date: January 30, 2021