Infection
Conditions
Interventions
Fasting vs after meal:0.125g once a day
Sponsors
The 1st affiliated hospital, school of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-45 years old male and female; 2) Male subjects weighing 50kg or more (including 50kg), female subjects weighing more than 45kg (including 45kg); body mass index [BMI=weight (kg)/height (m)2] within the range of 19-28kg/m2 Inside; 3) According to previous medical history, comprehensive physical examination and prescribed laboratory tests, the investigator determined that they were healthy subjects; 4) Women of childbearing age had a negative blood pregnancy test and were taken from 14 days prior to dosing to 6 months after the end of the study. Effective contraceptive measures; 5) Male volunteers must take effective contraceptive measures 14 days before dosing and up to 6 months after the end of the study and agree to not perform sperm donation within six months from the end of the study; 6) Fully understand the purpose of the trial, the nature of the trial, the study procedures, and possible adverse reactions, and voluntarily participate in the trial and sign an informed consent form (the process of obtaining informed consent meets GCP requirements); 7) Communicate well with the researcher, follow the requirements of the entire study, and be willing to stay in the Phase I clinical research ward as required.
Exclusion criteria
Exclusion criteria: 1. Can not tolerate venipuncture blood collection; 2. Positive for penicillin skin test, clearly have a history of allergies to the drug components or similar species, or a history of hypersensitivity to two or more other drugs and highly sensitive to food and environmental substances; 3. Have any history of serious clinical illness, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, amlodipine besylate tablets, human organisms, etc. Effectiveness of Shanghai DiSino Biopharmaceutical Co., Ltd. Immune system diseases and metabolic abnormalities; 4. Laboratory tests (blood routine, urine routine, blood biochemistry, etc.) and chest radiographs and electrocardiograms have clinically significant findings within 2 weeks before the test; 5. Hematological screening (HIV antibody or HBV surface antigen or HCV antibody or TP antibody) positive; 6. Women who are breastfeeding, pregnant or planning to become pregnant recently; 7. Positive pregnancy test; 8. Male and female subjects have not taken effective contraception or their spouse plans to have children within six months; 9. Persons with mental or legal disabilities; 10. Screening for history of prescription drug abuse and/or history of illegal drug abuse within the first 6 months of screening; 11. A person who has a history of alcohol abuse within the first 6 months of screening, drinking more than 14 units of alcohol per week (1 unit = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL of 40% alcohol, 5 oz or 150mL wine); 12. Smokers who smoke more than 5 cigarettes per day within the first 6 months of screening; 13. Those who are positive for drug abuse testing or alcohol testing; 14. Persons with history of hospitalization or surgery within 3 months prior to screening (except for appendicitis); 15. Participate in other drug clinical trials within 3 months before screening; 16. Blood donation or acute blood loss (400 mL) within the first 2 months of screening or intended donors within 1 month after the end of the trial; 17. Any other drug used within 2 weeks before the test; 18. Drink more than 1L of tea, coffee, and/or caffeinated beverages daily; 19. Those who do not understand the content of the informed consent and others who do not meet the criteria for the trial enrollment; 20. Researchers consider it inappropriate to participate in the trial (eg, frailty, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax; | — |
Countries
China
Contacts
Public ContactXingjiang Hu
The 1st affiliated hospital, school of Medicine, Zhejiang University
Outcome results
None listed