This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions. Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetic Parameter of Hydronidone: Cmax
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone: AUC0-t
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:AUC0-∞
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Tmax
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:t1/2
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:λz
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:CL/F
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:MRT
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Vz/F
Timeframe: Within 48 hours of administration
Pharmacokinetic Parameter of Hydronidone:Ratio of free drugsRatio of free drugs
Timeframe: Within 48 hours of administration
Difference in the main parameters AUC₀-t between patients with hepatic impairment and participants with normal hepatic function.
Timeframe: Within 48 hours of administration
Difference in the main parameters AUC₀-∞ between patients with hepatic impairment and participants with normal hepatic function.
Timeframe: Within 48 hours of administration
Difference in the main parameters Cmax between patients with hepatic impairment and participants with normal hepatic function.
Timeframe: Within 48 hours of administration