NCT04123769

Study on PK of Hydronidone in Patients and Special Population

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Hydronidone	First take Hydronidone capsule, single-dose and then Multiple-dose

Timeline

• Start date: 2019-09-03
• Primary completion: 2020-10-09
• Completion: 2021-01-30
• First posted: 2019-10-11
• Last updated: 2021-03-24

Locations

1 site across 1 country: China