| Eligibility |
Inclusion Criteria:
1. Age 18 ~ 45 years old, including boundary value;
2. Female subjects weigh =45kg, male subjects weigh =50kg, and body mass index (BMI) is
within the range of 19.0~26.0kg/m2 (body mass index = weight (kg)/height 2 (m2)),
including boundary values;
3. The subject has no plans to give birth or donate sperm/eggs for at least 3 months from
the signing of the informed consent form to the end of the study, and voluntarily take
effective non-drug contraceptive measures (including partners) during the trial
period;
4. Before the test, learn more about the nature, significance, possible benefits,
possible inconvenience and potential risks of the test. Able to understand the
procedures and methods of this research, willing to strictly abide by the clinical
trial protocol to complete the trial, and voluntarily sign an informed consent form.
Exclusion Criteria:
1. People with a known history of drug or food allergies;
2. Past or current history of any disease that may affect the safety of subjects
participating in the trial or the internal process of the research drug, including:
digestive system, blood system, circulatory system, urinary system, respiratory
system, nervous system, immune system, endocrine system, Those with a clear history of
mental disorders and metabolic disorders, or other diseases that are not suitable for
participating in clinical trials;
3. Those who have used drugs that affect the function of liver metabolic enzyme CYP3A4
within 30 days before the first administration (such as inducers-enzalutamide,
mitotane, carbamazepine, phenytoin, rifampin; inhibitors-clarithromycin, irradian)
Traconazole, ketoconazole, ritonavir, telithromycin, etc.), or those who have used
contraceptives within 30 days before administration;
4. Those who have used any drug within 14 days before the first dose;
5. Those who have taken a special diet (including grapefruit/grapefruit juice, chocolate,
food or beverages containing caffeine) within 48 hours before the first
administration, or have consumed excessive amounts of tea, coffee or beverages
containing caffeine every day for the past 1 month (Average more than 8 cups per day,
200 mL per cup);
6. Participate in drug clinical trials and take trial drugs as subjects within 3 months
before screening, or plan to participate in other clinical trials during the study
period;
7. Those who donated blood or lost more than 400 mL (excluding menstrual blood loss in
women) within 3 months before screening, received blood transfusion or used blood
products, or planned to donate blood during the trial period or within 1 month after
the end of the trial;
8. Those who have undergone major surgery within 3 months before screening, or plan to
undergo surgery during the study period;
9. Those who smoked more than 5 cigarettes a day on average in the 3 months before
screening, or who did not agree to ban smoking during the trial;
10. In the 6 months before screening, the average weekly alcohol consumption exceeded 14
units of alcohol (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits
with 40% alcohol content or 150 mL of wine with 12% alcohol content), Or those who do
not agree to abstain from alcohol during the trial;
11. The results of laboratory tests (blood routine, urine routine, blood biochemistry,
blood coagulation function) are judged by clinicians as abnormal and clinically
significant;
12. Those whose 12-lead ECG, physical examination or vital signs examination results are
judged by clinicians as abnormal and clinically meaningful;
13. Immunological examinations (hepatitis B surface antigen, hepatitis C virus antibody,
human immunodeficiency virus antibody, Treponema pallidum antibody) are positive;
14. Those with abnormal chest radiograph (posterior anterior position) and clinical
significance;
15. Women who are pregnant or breastfeeding;
16. Those who have a positive alcohol breath test;
17. Those who have a positive urine drug screening;
18. Those who have a history of drug abuse or drug abuse;
19. People with a history of difficulty in venous blood collection, intolerance to
venipuncture, or a history of fainting needles
20. Those who have difficulty swallowing, or have special dietary requirements and cannot
follow a uniform diet;
21. The investigator believes that the subject has any other factors that are not suitable
for participating in this trial (such as inability to understand the research
requirements, poor compliance, infirmity, etc.).
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