Phase 1Recruiting
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
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd. (Industry)
- Enrollment
- 56 planned
- Conditions
- Renal Insufficiency Chronic
- Interventions
- Hydronidone capsules
- Ages
- adults, older adults
- Registry
- NCT07262333
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞)
- The free plasma concentration of hydronidone
- The urine drug concentrations of hydronidone and its metabolites M3 and M4
- The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC%Extrap)
History
Primary completion expected
Last registry update
Started
Registered