Trials / Recruiting
RecruitingNCT07262333
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydronidone capsules | Take 90mg orally on an empty stomach on Day 1. |
Timeline
- Start date
- 2025-12-25
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2025-12-03
- Last updated
- 2026-04-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07262333. Inclusion in this directory is not an endorsement.