Anti infection
Conditions
Interventions
experimental group:etimicin sulfate injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, no gender limit; 2. Weight: male >= 50kg, female >= 45kg, body mass index (BMI) [= weight (kg)/height^2 (m^2)] between 19 and 26 (including boundary values); 3. Normal vital signs (systolic blood pressure should be between 90-140 mmHg, diastolic blood pressure should be between 60-90 mmHg; heart rate should be between 50-100 beats/min, both inclusive); 4. Physical examination, laboratory tests (blood routine, blood biochemistry and urine routine), and 12-lead electrocardiogram are normal, or abnormal but judged by the investigator to have no clinical significance; 5. No history of primary diseases of important organs, such as liver, kidney, digestive tract, blood, metabolism, etc., no history of mental and neurological diseases, no history of epilepsy, no history of anesthesia accident; 6. Be able to understand the procedures and methods of this study, voluntarily sign the informed consent form and strictly follow the clinical trial protocol to complete this trial.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to etimicin sulfate injection or aminoglycoside drugs, or have a history of drug allergy (including narcotics), allergic diseases, or allergic constitution; 2. Those with a history of drug abuse, obvious addiction to tobacco and alcohol and/or dependence on other substances (such as betel nut); 3. Participated in any clinical trials of drugs or medical devices within 3 months before screening; 4. Those who have serious infection, trauma or major surgical operation 4 weeks before screening; or acute disease with clinical significance (judged by the investigator) within 2 weeks before screening, such as gastrointestinal diseases, infections (such as respiratory or central nervous system infections, etc.); 5. Those who have taken any drugs (including vitamins and Chinese herbal medicines) within 14 days before administration; unless the principal investigator and the funding sponsor jointly believe that the drugs used have no effect on the safety and PK results of this trial, they can be included in the group; 6. Abnormal liver and kidney function tests and the investigators judged them to be clinically significant after re-examination; 7. Those who have a history of severe vomiting, dizziness, diarrhea, tinnitus or any other diseases or physiological conditions that can interfere with the test results; 8. Patients with positive screening results for any indicator of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody; 9. Blood donation or blood loss >=200mL within 30 days before administration; plasma donation or plasma exchange within 7 days before administration; 10. Those who do not smoke or drink alcohol or eat food or drink containing xanthine or caffeine, strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion within 2 days before enrollment; 11. Those who are expected to have surgery or hospitalization tendencies during the trial; 12. Pregnant and lactating patients; fertile patients who are unwilling to use contraception throughout the trial period; 13. Those who cannot tolerate venipuncture, and/or those who have a history of fainting with needles and blood; 14. The investigator believes that there are any factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic data; | — |
Countries
China
Contacts
Public ContactHan Xiaohong
Peking Union Medical College Hospital
Outcome results
None listed