drugset / Trial / NCT07262333
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
Phase 1
Recruiting
56 enrolled
Beijing Continent Pharmaceutical Co, Ltd.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2025-12-25
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydronidone | Small molecule | 90 mg | Oral |