Respiratory system infection(Community-acquired pneumonia)
Conditions
Interventions
single dose group:A total of 12 subjects (male: female = 1: 1) were stratified by sex followed by randomization according to the random numbers. They received single low dose (500/50 mg), medium dose
multi-dose group:complete the PK study after multiple doses of amoxicillin/ clavulanic acid (2000/200 mg q12h) up to the morning of day 8 (total of 15 doses)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Male or female healthy volunteers, 18-40 years old, and the age difference of the same group of enrolled subjects is not more than 10 years; 2. Health means that no clinically significant abnormality has been found through detailed medical history, physical examination, vital signs examination (including blood pressure, pulse, etc.), 12-lead electrocardiogram and laboratory examination; 3. Body mass index (BMI: weight kg/ height ?) between 18~25, and male weight >50 kg, female weight >45 kg; 4. Women of childbearing age, pregnancy test negative; Male and female volunteers who could use effective contraception during the study period and within 1 month after the end of the study: 5. No smoking, alcohol, tea, soda, chocolate, coffee, grapefruit juice, citrus juice and other drinks and foods containing caffeine or xanthine 24h before and during the study period; 6. Can voluntarily sign the informed consent; 7. Willing and able to follow research schedules, procedures, laboratory examinations and other relevant examinations.
Exclusion criteria
Exclusion criteria: 1. Patients with a clear history of chronic cardiovascular, liver, kidney, lung, blood, endocrine, digestive, metabolic, musculoskeletal system and myelosuppression: 2. Patients who are allergic to penicillin (positive in penicillin skin test) and allergic to other ß-lactam antibiotics, such as cephalosporins; 3. Penicillin-related jaundice or liver function changes in the past; 4. People with allergic constitution and past history of any drug allergy; 5. The average value of 12-lead ECG during screening exceeded the standard :PR>240ms, QRS>110ms, QTcF>430ms for male (QTcF results in II-lead ECG should be measured according to machine reading and confirmed by the investigator), and QTcF>450ms for female (lead II should be measured according to machine reading) OTcF results in ECG and confirmed by investigators), sinus bradycardia (heart rate 140 mmHg or 90mmHg, pulse 100 times/min during screening: 7. Previous history of seizures or convulsions; 8. Previous history of heparin allergy or history of heparin-induced thrombocytopenia; 9. Serological test positive for human immunodeficiency virus (HIV), syphilis antibody, hepatitis B or hepatitis C virus; 10. Patients who donated blood or plasma =400ml within 3 months before entering the study; 11. Those who have a history of alcohol or illicit drug abuse, or who test positive for alcohol or illicit drug abuse at the time of screening or on day 1; 12. Smokers who smoked more than 10 cigarettes (or equivalent amount of tobacco) per day for 6 weeks before the study began; 13. Those who cannot smoke or drink during the test; 14. Patients who had used any liver enzyme inducer barbiturates (e.g., phenobarbital, carbamazepine, ethanol, grupulvin, ammetapropyl, phenytoin, rifamepine) or liver enzyme inhibitors (chloramphenicol, cimetidine, ciprofloxacin, diltiazem, erythromycin, imimazine, isoniazid, ketoconazole, metoprolol, metronidazole, miconazole, or birth control pills) within 30 days before entering the study Etc.); 15. Those who have received any investigational drug within 3 months prior to entering the study; 16. Use of any prescription drug or Chinese herbal medicine or any drug that may affect the results of this study in the 2 weeks prior to entering the study; 17. Any ±10% laboratory test value exceeding the upper or lower limit of the laboratory reference value and judged by the investigator to be clinically significant; 18. Female pregnancy test positive or currently breastfeeding female volunteers; 19. Any pre-existing or existing disease or other condition that the investigator determines may affect the evaluation of the investigational drug; 20. Subjects are researchers or their subordinate researchers or relatives; 21. The researcher judged that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug peak concentration;Drug valley concentration;T1/2, half time;MRT, Mean retention time;AUC0-t;AUC0-8;Apparent distribution volume;Total clearance rate;Renal clearance rate;AI, accumulation index;PTR, pulse transit rate;PTA, probability of target attainment;CFR, cumulative fraction of response; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE, adverse event;Laboratory abnormalities; | — |
Countries
China
Contacts
Public ContactZhang, Jing/ Zhang, Yingyuan
Huashan Hospital, Fudan University
Outcome results
None listed