| Eligibility |
Inclusion Criteria:
1. Subjects fully understand the purpose, nature, methods and possible adverse reactions
of the experiment, volunteer as subjects, and sign an informed consent form before any
research procedure starts;
2. Male and female subjects aged from 18 to 60 years (including 18 and 60 years);
3. Male weight =50.0 kg, female weight =45.0 kg, body mass index (BMI) in the range of
19.0~26.0 kg/m2 (including the critical value);
4. The subject has no history of chronic diseases or serious diseases such as
cardiovascular, liver, kidney, blood and lymph, endocrine, immune, mental, nervous,
gastrointestinal system, etc., and is in good general health;
5. During screening, vital signs examination, physical examination, clinical laboratory
examination (blood routine examination, urine routine examination, blood biochemistry
examination, hepatitis B, hepatitis C, AIDS and syphilis examination, coagulation
function), pregnancy examination (only for women), chest X-ray examination, 12-lead
electrocardiogram and nicotine examination, the results show that there is no
abnormality or no clinical significance;
6. Subjects (including male subjects) have no pregnancy plans and voluntarily take
effective contraceptive measures from two weeks before the screening date to six
months after the last administration, and have no plans for sperm donation or egg
donation; Female subjects/male subjects and their female partners of childbearing age
did not have unprotected sex within one month before the screening, and female
subjects agreed not to use contraceptives from the screening to the end of the trial;
7. Subjects can communicate well with researchers, and understand and abide by the
requirements of this research.
Exclusion Criteria:
1. those who have a history of allergy to research drugs or their adjuvants, or are
allergic to drugs, food, pollen or have a specific history of allergy (asthma,
allergic rhinitis, eczema), etc.;
2. Have a history of dysphagia or any gastrointestinal diseases that affect drug
absorption;
3. Anyone who has a history of surgery or trauma that may affect the safety of the trial
or the in vivo process of the drug, or who plans to have surgery during the study
period;
4. Any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health
products were taken orally within 28 days before the screening, especially any drugs
that change the activity of liver enzymes (such as: inducers-barbiturates,
carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors--SSRI
antidepressants, cimetidine, diltiazem macrocyclic lipids, nitroimidazoles, sedatives
and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.);
5. Screening those who have a history of drug abuse within 6 months before;
6. Screening those who have used drugs within the first 3 months;
7. Screening those who have been vaccinated within 2 months before screening;
8. Those who smoke more than 5 cigarettes per day within 3 months before screening, or
can't stop using any tobacco products during the trial period;
9. Drinking more than 14 units per week (1 unit = 17.7 mL of ethanol, that is, 1 unit =
357 mL of 5% alcohol beer or 43 mL of 40% alcohol liquor or 147 mL of 12% alcohol
wine) within 3 months before screening, or those who can't abstain from drinking
during the experiment;
10. Those who drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups,
1 cup =250 ml) every day within 3 months before screening;
11. those who have participated in other drug clinical trials within 3 months before
administration or who have not participated in clinical trials by themselves;
12. Blood donation within 3 months before screening includes blood component or massive
blood loss (=450mL), and those who receive blood transfusion or use blood products are
planned to donate blood during the test period;
13. The subject (female) is in lactation;
14. Those who can't tolerate venipuncture and have a history of fainting from needles and
blood;
15. Those who have special requirements for diet and cannot accept a unified diet;
16. Screening those who have had significantly abnormal diet (such as dieting and low
sodium) within 1 month before screening;
17. Subjects judged by other researchers to be unsuitable for participation
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