drugset / Trial / NCT04123769

Study on PK of Hydronidone in Patients and Special Population

NCT04123769

Phase 1 Completed 8 enrolled Beijing Continent Pharmaceutical Co, Ltd.
NaSingle-groupOpen-labelBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydronidone Small molecule Oral