Renal insufficiency
Conditions
Interventions
Mild renal insufficiency group:600 mg TBN tablets
Moderate renal insufficiency group:600 mg TBN tablets
Severe renal insufficiency group:600 mg TBN tablets
Healthy young and middle-aged group:600 mg TBN tablets
Healthy elderly group:600 mg TBN tablets
Sponsors
Yanbian University Affiliated Hospital (Yanbian Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The following criteria apply to subjects with renal insufficiency (groups 1 to 3) : 1.Male or female subjects aged 18 to 75 years old (including 18 and 75 years old); 2.BMI >= 19 kg/m^2 and =50 kg for male subjects and >=45 kg for female subjects; 3.Patients diagnosed with renal insufficiency had mild renal insufficiency (eGFR: 60 ~ 89 mL/min/1.73m^2, including boundary values) or moderate renal insufficiency (eGFR: 30 to 59mL/min/1.73m^2, including the boundary value), or severe renal insufficiency (eGFR: 15 to 29 mL/min/1.73m^2, including the boundary value), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4. Stable progression of renal insufficiency, i.e., no clinically significant disease progression at least 3 months prior to screening (based on the subject's medical history); 5. Pre-enrollment medical history (within 6 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and various tests related to the test, the subjects were judged by the investigator to be in good condition and could participate in the clinical trial. Example: Subjects with mild chronic complications, degenerative arthritis, diabetes, hypertension, hyperlipidemia, etc., can be included in the trial; 6.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily. The following criteria apply to the healthy young and middle-aged group (Group 4) : 1. Male or female subjects aged 18 to 65 years old (including 18 and 65 years old), and the average age of subjects with renal dysfunction is within the range of +/- 10 years; 2.BMI >= 19 kg/m^2 and =50 kg for male subjects and >=45 kg for female subjects; 3.Normal renal function (eGFR: 90 ~ 130 mL/min/1.73m^2, including 90 mL/min/1.73m^2, excluding 130 mL/min/1.73m^2), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4.Pre-enrollment medical history (within 3 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and all tests related to the test were normal or abnormal without clinical significance; 5.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily. The following criteria apply to the healthy elderly group (Group 5) : 1.Male or female subjects aged 65-75 years (excluding 65 years old, including 75 years old); 2.BMI >= 19 kg/m^2 and =50 kg for male subjects and >=45 kg for female subjects; 3.Normal renal function (eGFR: 90 ~ 130 mL/min/1.73m^2, including 90 mL/min/1.73m2, excluding 130 mL/min/1.73m^2), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4.Pre-enrollment medical history (within 3 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and all tests related to the test were normal or abnormal without clinical significance; 5.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily·
Exclusion criteria
Exclusion criteria: The following criteria apply to subjects with renal insufficiency (groups 1 to 3) : 1.The investigator determines that, in addition to renal insufficiency, there is a medical condition that may affect the safety of the trial or metabolic processes in the body of the drug, including but not limited to: Diseases of the heart, liver, digestive tract, immune system and respiratory system, especially any gastrointestinal diseases that affect the absorption of drugs (e.g. symptoms of irritable bowel syndrome, history of bowel disease or inflammatory bowel), as well as active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.; 2. Patients diagnosed with memory dysfunction, Alzheimer's disease, or mental illness, who are difficult to cooperate with the completion of clinical trials; 3.The subjects had the following diseases: acute renal failure, nephrotic syndrome, renal artery stenosis, or urolithiasis considered by the researchers to be of greater risk; 4.Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial; 5.Gross hematuria or crystalluria occurred during the screening period, and the researcher considered it clinically significant; 6.Abnormal liver function test results (AST or ALT or ALKP >= 2x ULN), or other known liver diseases, such as cirrhosis; 7.When screening for infectious diseases, one or more of the four tests for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), AIDS (HIV), syphilis (TP) were positive, and the investigator judged that there was clinical significance; 8.Patients with a history of drug abuse or positive urine addiction screening within 6 months before screening; 9.Subjects are taking drugs known to affect renal tubule secretion and/or reabsorption through interaction with transporters (see Prohibited drugs) and cannot stop taking these drugs during the trial; 10.Those allergic to ligustrazine or experimental drug excipients (mannitol, hydroxypropyl cellulose, crosslinked POvinone, talc powder, sodium bicarbonate, magnesium stearate, copolymer of methacrylate and ethyl acrylate, triethyl citrate, titanium dioxide) in the past; 11.Those who received the vaccine within 3 months before administration; 12.Regular drinkers in the six months prior to screening, i.e., those who drink more than 14 units of alcohol per week (1 unit =360 mL beer with 5% alcohol, or 45 mL spirits with 40% alcohol, or 150 mL wine with 12% alcohol), or who do not agree to stop alcohol intake 24 hours prior to administration and during hospitalization, Or positive for alcohol breath test; 13.do not agree to prohibit the consumption of caffeinated foods or beverages (such as coffee, tea, chocolate and caffeinated carbonated beverages, colas, etc.), grapefruit, grapefruit juice or foods containing opium poppy for 24 hours prior to administration and during hospitalization; 14.Smoking >=5 cigarettes/day in the 3 months before screening, and cannot comply with the anti-smoking manager during the test period; 15.Patients with blood loss or blood donation of more than 200 mL within 3 months before administration, or 2 therapeutic amounts of platelets within 1 month (1 therapeutic amount =12 U platelets); 16. is receiving another clinical trial drug, or has used another clinical trial drug within 3 months prior to administration; 17.No effective contraceptive measures were taken 30 days before screening, or no effective con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters ;Proportion of subjects experiencing serious adverse reactions between the time of dosing and the end of the trial.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing adverse reactions between the time of dosing and the end of the trial.; | — |
Countries
China
Contacts
Public ContactXionghu Shen, Enyue Yang
Yanbian University Affiliated Hospital
Outcome results
None listed