Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls

This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions. Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).

NCT Number	NCT07394309
Lead Sponsor	Beijing Continent Pharmaceutical Co, Ltd. Collaborators: The First Affiliated Hospital of Bengbu Medical University
Conditions	Liver Fibrosis
Enrollment	30 participants
Start Date	2026-03-25
Primary Completion	2026-05-11 (estimated)
Study Completion	2026-05-11 (estimated)
Updated on ClinicalTrials.gov	2026-08-13