A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability. Based on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.

NCT Number	NCT07262333
Lead Sponsor	Beijing Continent Pharmaceutical Co, Ltd. Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions	Renal Insufficiency Chronic
Enrollment	56 participants
Start Date	2025-12-25
Primary Completion	2026-12-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-13