Suitable forvarious infections caused by sensitive bacteria
Conditions
Interventions
Agroup:TRR
Bgroup:RTR
Cgroup:RRT
D group:TRR
E group :RTR
F group:RRT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: All of the following criteria are met to be included in the group: 1. Healthy male and female subjects aged 18-45 years (including 18 and 45); 2. Body weight: male subjects should not be less than 50 kg, female subjects should not be less than 45 kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be in the range of 19.0 to 26.0 kg/m2 within (including boundary values); 3. During the screening period, physical examination, vital signs, electrocardiogram, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function), hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, HIV antibody, the results were normal or were The investigator judges that the abnormality has no clinical significance; 4. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as subjects, and sign an informed consent form before any research procedure begins; 5. The subjects can communicate well with the researcher and can complete the research in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: Anyone who has one of the following conditions cannot be included in this trial: 1. Allergic constitution or a history of food or drug allergy, especially those who are known to be allergic to any of the ingredients in cephalosporins, penicillin products and their excipients, or those with a positive penicillin skin test; 2. Acute and chronic digestive tract diseases, liver, kidney, endocrine, cardiovascular, neurological, mental, lung, tumor, immune, blood or metabolic disorders or any other diseases or any other diseases judged by the investigator to have clinical significance, or have these diseases Those with a medical history who will jeopardize their safety or affect the results of the study if they participate in the trial; 3. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion; 4. Those with poor vascular puncture conditions, unable to tolerate venipuncture, and those with a history of needle fainting or haemorrhage; 5. Lactose intolerance (those who have had milk diarrhea); 6. Those with a history of drug abuse within 6 months before administration, or those with positive urine drug screening; 7. Those who donated blood or lost a large amount of blood (more than 400 mL), received blood transfusion or used blood products within 3 months before screening; 8. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan within 2 weeks before administration to 6 months after the end of the study, are unwilling to take adequate and effective contraceptive measures ( For specific contraceptive measures, see Appendix 1), or have sperm or egg donation plans; 9. Have used any drugs that inhibit or induce liver metabolism of drugs within 28 days before taking the study drug (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors) --SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines), or CYP3A4, P- gp inducers (such as rifampicin); 10. Those who use any prescription drugs, Chinese herbal medicines, over-the-counter drugs, health products and functional vitamins within 2 weeks before administration; 11. Those who smoked more than 5 cigarettes on average per day in the 3 months before screening, or who could not stop using any tobacco products during the trial; 12. Drink more than 14 units per week within 3 months before screening (1 unit of alcohol is about 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or those who cannot abstain from alcohol during the test; 13. Alcohol breath test results greater than 0.0 mg/100 mL; 14. 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; 15. Those who have consumed dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared from them within 14 days before taking the study drug; 16. Those who have eaten chocolate, any food or drink containing caffeine or xanthine within 48 hours before taking the study drug and other special diets that affect the absorption, distribution, metabolism and excretion of the drug; 17. Those who have participated in clinical trials of other drugs and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood concentration;Area under the blood drug concentration-time curve from 0 to the last time point T; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed