To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild, Moderate Liver Impairment and Normal Liver Function After a Single Oral Administration
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
• 1\. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
• 2\. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);
• 3\. The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
• 4\. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least 28 days (or up to 14 days for patients with moderate liver function) before taking the study drug) due to primary liver disease (e.g., autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc.); Patients were classified as grade A/mild (Child-Pugh score: 5-6) or grade B/moderate (Child-Pugh score: 7-9) according to the Child-Pugh classification within 72 hours before taking the study drug; Among them, the researchers used standard diagnosis and treatment methods, combined with the patient's past medical history, laboratory tests, liver biopsy or imaging examination and other documents to diagnose chronic liver function impairment, and then evaluated according to the Child-Pugh classification.
• 5\. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant diseases for at least 28 days (or 14 days for patients with moderate liver function) before taking the study drug, and who do not need to adjust the medication (including the type, dose, or frequency of medication); Or those who do not use drugs;
⁃ In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.