| Eligibility |
Inclusion Criteria:
1. Sign informed consent before the test, and fully understand the test content, process
and possible adverse reactions; And be able to complete the research according to the
requirements of the test plan;
2. The subjects (including their partners) are willing to voluntarily take effective
contraceptive measures from screening until 2 weeks after the last study drug
administration, as specified in Appendix 1;
3. Age 18-70 years old (including the critical value), both male and female;
4. The weight of male subjects is not less than 50 kg, and the weight of female subjects
is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off
value);
5. (Only for subjects with normal liver function) The demographic mean of subjects in the
normal liver function group (Group C) at screening must meet the following matching
criteria:
1. The body weight was matched with that of the liver function impairment group
(group A + group B), with an average of ±10 kg;
2. Age matching was performed with the liver function impairment group (group A +
group B), and the mean was ±10 years old;
3. Gender matching was performed with the liver function impairment group (group A +
group B), with an average of ±1 cases;
6. (Only for subjects with normal liver function) Normal or abnormal clinical laboratory
tests (blood routine, blood biochemistry, urine routine, coagulation function) have no
clinical significance.
7. (Only for subjects with normal liver function) No prior serious primary diseases of
major organs, including but not limited to gastrointestinal, respiratory, kidney,
liver, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and
cerebrovascular diseases
8. (Only for subjects with liver function impairment) Those who had not taken medication
within 4 weeks prior to screening, or who had at least 4 weeks of stable medication
for liver impairment and/or other comorbidification requiring long-term treatment
9. (Only for subjects with liver function impairment) Patients with liver insufficiency
due to previous primary liver disease with Child-Pugh grade A or B.
Exclusion Criteria:
1. allergy, or known or suspected allergy to any of the ingredients in the
investigational drug;
2. Smoking an average of more than 10 cigarettes per day in the 3 months before
screening;
3. Alcoholics in the preceding 3 months, i.e. drinking more than 14 units of alcohol per
week (1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine);
4. Drug abusers or drug urine screening test positive;
5. Blood donation or blood loss =400 mL within 3 months before screening, or receiving
blood transfusion;
6. Major surgery or surgical incision not fully healed within 6 months prior to
screening;
7. Had been exposed to DPP-IV inhibitors such as sitagliptin, saxagliptin, ligagliptin,
vigagliptin within 1 month prior to administration;
8. Chinese herbal medicine was taken within 2 weeks before administration;
9. Have malignant tumors, or a history of malignant tumors within 5 years prior to
screening (except for treated non-melanoma skin tumors with no signs of recurrence,
and resected cervical intraepithelial neoplasia);
10. Patients with a history of severe hypoglycemia;
11. History of recurrent urinary tract infections or/and genital fungal infections;
12. Those who are expected to have a tendency to undergo surgery or be hospitalized during
the trial;
13. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time
of screening;
14. 14.12- Patients with clinically significant ECG abnormalities (such as
tachycardia/bradycardia requiring medical treatment, degree II-III atrioventricular
block, or QTcF (male) =470ms, QTcF (female) =480ms), or other clinically significant
abnormalities determined by the investigator and judged by the investigator to be
unsuitable for participation in this study;
15. Female subjects were breastfeeding or had positive pregnancy results during the
screening period or during the test;
16. 16. Serum creatinine values were estimated glomerular filtration rate calculated using
the chronic kidney disease epidemiology collaboration CKD-EPI formula filtration rate
eGFR) < 90 ml/min;
17. 17. Anyone who has consumed any food or drink containing alcohol (or positive breath
test for alcohol), grapefruit juice/grapefruit juice, methylxanthine (such as coffee,
tea, cola, chocolate, energy drinks), strenuous exercise or other factors affecting
drug absorption, distribution, metabolism, excretion or other factors within 2 days
prior to administration;
18. 18 Those who had any factors deemed inappropriate by the investigator to participate
in the study.
19. (Only for subjects with normal liver function) Participants who have participated in
clinical trials of any drug or medical device within 3 months prior to screening
(subject to acceptance of the drug)
20. (Only for subjects with normal liver function) Hepatitis B surface antigen, hepatitis
C virus antibody, human immunodeficiency virus antibody or syphilis antibody detection
of any index screening positive excluded.
21. (Only for subjects with liver function impairment) Participants who have participated
in clinical trials of any drug or medical device within 1 month prior to screening
(subject to acceptance of the drug)
22. (Only for subjects with liver function impairment) A history of liver transplantation
23. (Only for subjects with liver function impairment) Subjects with liver failure, or
liver cirrhosis with complications such as hepatic encephalopathy, hepatocellular
carcinoma, esophageal variceal hemorrhage and other complications deemed inappropriate
by the researchers to participate in the study
24. (Only for subjects with liver function impairment) In addition to the primary liver
disease itself, a history of any serious disease, or a medical history or
abnormalities that the investigator believes may affect the results of the trial,
and/or clinically significant clinical laboratory tests, including, but not limited
to, a history of circulatory, endocrine, nervous, digestive, urinary, or blood,
immune, psychiatric, and metabolic disorders.
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