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.
(1) Healthy Chinese subjects, with an estimated glomerular filtration rate (absolute eGFR) meeting the following conditions: ≥ 90 mL/min and < 130 mL/min; (limited to healthy subjects)
(2) Patients diagnosed with renal dysfunction, with the estimated glomerular filtration rate (absolute eGFR) for mild, moderate, and severe renal dysfunction meeting the following standards respectively: 1. Mild renal dysfunction 60-89 mL/min; 2. Moderate renal dysfunction 30-59 mL/min; 3. Severe renal dysfunction 15-29 mL/min; (limited to patients with renal dysfunction)
(3) Age 18-70 years old, inclusive of 18 years and 70 years old;
(4) Weight: Male ≥ 50 kg, female ≥ 45 kg, 18 ≤ BMI ≤ 28 (BMI = weight (kg) / height2 (m2));
(1) If the subject has participated in any other clinical trial within the three months prior to the trial;
(2) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, excluding renal insufficiency, including but not limited to: previous or existing diseases of the heart, liver, digestive tract, immune system and respiratory system (especially any gastrointestinal diseases that affect drug absorption, such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history, active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to patients with renal insufficiency);
(3) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, including but not limited to: previous or existing diseases of the heart, liver, kidney, endocrine, digestive tract, immune system and respiratory system (especially cardiovascular diseases including those with cardiovascular disease risk, any gastrointestinal diseases that affect drug absorption (such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history), active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to healthy subjects);
(4) If the subject has an allergic constitution: if there is a history of allergy to two or more drugs (including the trial drug), food, or lactose intolerance;
Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator