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.
Age range
18 Years – 70 Years
Sex
ALL
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The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞)
Timeframe: 48 hours after administration
The free plasma concentration of hydronidone
Timeframe: 48 hours after administration
The urine drug concentrations of hydronidone and its metabolites M3 and M4
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC%Extrap)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4( AUC0-t)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(CL/F)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Vd/F)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Cmax)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(T1/2)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(λz)
Timeframe: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Tmax)
Timeframe: 48 hours after administration