| Eligibility |
Inclusion Criteria:
1. Healthy male or female subjects, male and female equally;
2. Aged between 18 and 50 at the time of screening (including boundary values); Male
weight =50.0kg, female weight =45.0kg; All subjects had a body mass index (BMI)
between 19 and 28kg/m2 (including boundary values);
3. Participate voluntarily and sign informed consent to complete the experiment according
to the research protocol.
Exclusion Criteria:
Subjects who meet one of the following conditions will not be enrolled in the trial:
1. a person who is allergic to, or is allergic to, 2 or more drugs or foods, or is known
to have a history of allergy to the test preparation and any of its components or
related preparations;
2. Patients with a history of clinically serious diseases such as nervous system, blood
circulatory system, digestive system, urinary system, respiratory system, immune
system, endocrine system, malignant tumor, mental and metabolic abnormalities, or any
clinically significant diseases judged by researchers to be in an active period or
unstable state;
3. Based on vital signs (including sitting blood pressure, pulse, and body temperature),
physical examination, 12-lead electrocardiogram examination, and laboratory
examination (including routine blood routine, urine routine, blood biochemistry, and
coagulation function), the investigator determined that the abnormality was clinically
significant;
4. postural hypotension;
5. a1-antitrypsin deficiency;
6. Patients with difficulty in venous blood collection;
7. People with a history of fainting needles and fainting blood;
8. A history of drug abuse within the last two years (including repeated and heavy use of
various narcotic drugs and psychotropic substances for non-medical purposes);
9. Excessive smoking within 3 months before screening (average > 5 cigarettes/day) or
unable to stop using any tobacco products during the test period or smokers within 48
hours before screening;
10. Excessive daily consumption of tea, coffee or caffeinated beverages (more than 8 cups
per day, 1 cup =250mL) in the 3 months before screening;
11. alcoholics (i.e. men drinking more than 28 standard units per week, women drinking
more than 21 standard units per week, 1 standard unit containing 14g of alcohol, such
as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or regular drinkers
(i.e. more than 14 standard units per week) in the six months prior to screening;
12. Positive alcohol breath test (test result greater than 0.0mg/100mL);
13. Hepatitis B surface antigen (HBsAg), hepatitis C virus(HCV) antibody, syphilis
antibody and human immunodeficiency virus(HIV) antibody test one or more positive;
14. Positive urine screening for drug abuse (including morphine, methamphetamine,
ketamine, dimethylene dioxyamphetamine, tetrahydrocannabinol, cocaine);
15. Abnormal chest X-ray or CT findings with clinical significance;
16. Abdominal B-ultrasonography (liver, bile, pancreas, spleen and kidney) with abnormal
results and clinical significance;
17. Severe acute bacterial, viral or fungal infection within 4 weeks prior to screening;
18. Patients who had used any protease drugs (such as chylase, indinavir sulfate,
ritonavir, bortezomib, isazzomib citrate, etc.) within 4 weeks before screening;
19. Use of any prescription or over-the-counter drugs, as well as any functional vitamins
or Chinese herbal products within 2 weeks prior to screening;
20. Blood donation or blood loss greater than 400mL within 3 months before screening
(except physiological blood loss);
21. Vaccinated within 1 month before screening, or planned to be vaccinated during the
study period and within 1 month after the study ends;
22. Those who had undergone surgery within 3 months prior to screening or planned to
undergo surgery during the trial;
23. Participants who participated in any drug clinical trial as a subject within 3 months
before enrollment;
24. have consumed a special diet (including grapefruit, chocolate, tea, cola, or any food
or beverage containing caffeine, alcoholic beverage, or other food or beverage that
affects the absorption, distribution, metabolism, or excretion of drugs) in the 48
hours prior to screening;
25. The subjects or their partners do not wish to use one or more non-drug contraceptive
methods (such as total abstinence, condoms, Icontraceptive rings, ligation, etc.) for
contraception during the trial period or have pregnancy plans within 3 months after
the end of the study; Or screening women with positive pregnancy tests or
breastfeeding women;
26. With magnetic resonance examination contraindications: metal implant, claustrophobia,
etc.;
27. Other situations in which the investigator considers that participation in the trial
may not be appropriate. -
|
