Actively Recruiting
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-04-06
56
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Beijing Continent Pharmaceutical Co, Ltd.
Lead Sponsor
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Chinese adults aged 18 to 70 years with estimated glomerular filtration rate (eGFR) between 90 and 130 mL/min
- Patients aged 18 to 70 years diagnosed with renal dysfunction classified as mild (eGFR 60-89 mL/min), moderate (eGFR 30-59 mL/min), or severe (eGFR 15-29 mL/min)
- Male participants weighing at least 50 kg and female participants weighing at least 45 kg, with body mass index (BMI) between 18 and 28
- Agree to abstain from smoking, alcohol, fruit juices, caffeine, and tea from 24 hours before until the end of the trial
- Ability to understand and voluntarily sign informed consent and comply with study requirements
You will not qualify if you...
- Participation in any clinical trial within 3 months prior to the study
- Any disease affecting drug safety or processing including heart, liver, digestive, immune or respiratory diseases, excluding renal insufficiency
- History of allergies to two or more drugs, foods, or lactose intolerance
- Use of drugs that induce or inhibit liver enzymes within 28 days before dosing
- Use of drugs affecting SULT and UGT enzymes within 7 days prior to dosing
- History of fainting or intolerance to blood draws
- Excessive consumption of caffeine or tea, or intake of foods or drinks that affect liver metabolism within 24 hours before dosing
- Blood donation or large blood loss within 3 months before dosing or planned during the study
- Acute illness during screening or before dosing
- Pregnancy, breastfeeding, or unwillingness to use contraception during and after the study
- Recent or planned surgery affecting drug metabolism
- History of drug abuse
- Smoking more than 5 cigarettes daily within 14 days before screening or inability to stop tobacco use during the trial
- Clinically significant abnormalities in physical exams, ECG, lab tests excluding those due to renal insufficiency
- Positive tests for nicotine, alcohol, drugs, hepatitis B, hepatitis C, syphilis, or HIV
- Any condition affecting informed consent or study compliance as determined by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China
Actively Recruiting
Research Team
L
Ling Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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