To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage

Exclusion Criteria

• •1\. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other malignant tumors; Patients with hepatorenal syndrome; Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion; Patients with complications such as hepatic encephalopathy (according to Child-Pugh criteria), liver failure, esophageal and gastric varices bleeding, severe/advanced ascites or pleural effusion requiring puncture drainage and albumin supplementation, who were considered by the investigator to be unsuitable;
• •2\. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs within 1 year before screening, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immune and other diseases, judged by the investigator to be not suitable for the trial;
• •3\. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), Unstable angina pectoris, coronary artery/peripheral artery bypass grafting, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism;
• •4\. (asking) a history of depression or suicidal tendencies;
• •5\. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery within 3 months before screening, and the investigators thought that the absorption of drugs was affected;
• •6\. (Inquiry) patients who lost blood or donated more than 400mL of blood within one month before screening, or received red blood cell transfusion;
• •7\. (Inquiry) Liver function fluctuation (e.g., active hepatitis), rapid deterioration (e.g., advanced ascites, fever, active gastrointestinal bleeding), CTCAE 5.0 common adverse event grade ≥ 2, ongoing arrhythmia, atrial fibrillation of any grade during screening;
• •8.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \<1.0×109/L; (c) hemoglobin (HGB) \<90 g/L; (d) platelet level \<50×109/L; (e) subjects with alpha-fetoprotein (AFP) \>50 ng/mL and suspected hepatocellular carcinoma;
• •9\. (Inquiry) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic condition (such as allergic to two or more drugs, foods or pollens), or known allergic to PDE4 inhibitors (such as apast, roflumilast, etc.);
• •10\. (inquiry) those who had a history of drug abuse in the past 5 years or drug abuse in the past 3 years before screening;
• •11\. Screen-positive for drug abuse (except those screen-positive for drug abuse due to concomitant medication);
• •12\. Positive breath alcohol test (alcohol concentration \>0mg/L);
• •13\. (Inquiry) who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mL of 40% liquor or 147 mL of 12% wine), or who could not abstain from alcohol during the study;
• •14\. (Inquiry) who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study;
• •15\. (Inquiry) subjects who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) per day in the previous 3 months;
• •16\. Having one or more of the tests for hepatitis B, C, HIV and syphilis clinically significant;
• •17\. (Inquiry) who participated in clinical trials of other drugs/devices within 3 months before screening and used the trial drugs/devices;
• •18\. (Inquiry) who had received drugs with definite potential hepatotoxicity (such as acetaminophen, statins, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, rifampicin, etc.) for 7 consecutive days or more within 3 months before screening;
• •19\. (Inquiry) Use of any drugs (e.g., inductors-barbiturates, pioglitazone, carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepatic drug-metabolizing enzymes within 30 days before screening; Inhibitors: SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, isoniazid);
• •20\. (Inquiry) who used prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines other than those used for liver function impairment and other concomitant diseases within 2 weeks before screening;
• •21\. (Inquiry) any caffeine/xanthine/food or drink (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine/may affect the absorption, distribution, metabolism, excretion of drug in the judgment of the investigator during the period from screening to day -1 of admission, or unable to stop the intake of the above food or drink during the trial;
• •22\. (Asking) pregnant or lactating women, or subjects (including male subjects) who have plans to give birth or donate sperm or eggs from two weeks before the trial to six months after the last dose of drug, unwilling or not to take effective contraceptive measures;
• •23\. (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;
• •24\. (inquiry) with a history of epileptic seizures;
• •25\. (Inquiry) Those who cannot tolerate venipuncture and/or have a history of dizzy with blood and needles;
• •26\. Subjects with other factors considered by the investigator to be ineligible for the trial.