None listed
Conditions
Interventions
Single dose group:intravenous infusion colistin sulfate
Multdose group:intravenous infusion colistin sulfate 10000unit/kg, q12h
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
19 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 19-45 years (including 19 and 45 years old); 2. Weight requirements: weight is 50 ~ 70 kg, body mass index (BMI) range is 19 ~ 26, body mass index = weight (kg) / height (m) 2; 3. Patients with normal or abnormal history, physical examination, vital signs, 12 lead ECG and laboratory examination without clinical significance; 4. The subjects should take effective contraceptive measures during the trial (1) Female subjects must meet the following conditions: Non pregnancy or lactation period; Has undergone surgical sterilization or menopause for at least 1 year; or Women of childbearing age were tested negative for blood pregnancy before enrollment; they agreed to use an effective contraceptive method (such as oral contraceptive, spermicide and condom, or intrauterine device) throughout the study period; they agreed that the contraceptive method used during the whole study period did not change; or they agreed to abstain during the whole trial period; (2) Male subjects of childbearing age agreed to use effective barrier contraceptive measures (such as spermicide and condom) during the trial period, or their partners implemented the effective contraceptive methods of female subjects mentioned above, or agreed to abstain from sex during the whole trial period; 5. Patients who can sign informed consent voluntarily; 6. Patients willing to follow the trial process.
Exclusion criteria
Exclusion criteria: 1. Patients with previous or current gastrointestinal diseases (such as chronic bowel disease, inflammatory bowel disease), respiratory disease (such as chronic obstructive pulmonary disease), nervous system disease (with history of epilepsy or convulsion), metabolic disorder (such as diabetes), malignant tumor, autoimmune disease, cardiovascular disease and previous history of hearing loss; 2. Patients with known or suspected allergy to polymyxin drugs or allergic constitution; 3. Patients who had been hospitalized for surgery within 3 months before screening; 4. Patients with a history of acute infection within 2 weeks; 5. Patients with blood donation or blood loss > 400 ml within 3 months; 6. Patients who have used drugs known to have damage to certain organs within 3 months; 7. Patients who have participated in clinical studies of other drugs within 3 months; 8. When screening, the vital signs were in accordance with any of the following criteria: resting systolic blood pressure greater than 140 mmHg or less than 90 mmHg; diastolic blood pressure greater than 90 mmHg or less than 50 mmHg; pulse rate greater than 100 beats / min or less than 50 beats / min; body temperature > 37.5 dgrees (tympanic temperature (ear temperature)); 9. Patients with abnormal 12 lead ECG and clinical significance, including QTCF > 450 msec, evidence of atrial fibrillation, atrial flutter, complete bundle branch block, preexcitation syndrome or cardiac pacemaker, and other patients with clinically significant ECG abnormalities; 10. Patients with habitual drinking within 3 months (drinking more than 14 units of alcohol per week, 1 unit = 360 ml beer, or 45 ml strong liquor with 40% alcohol content, or 150 ml wine), who could not abstain from drinking during the test period, or those who were positive for alcohol screening during the screening period; 11. Patients who smoked more than 5 cigarettes or equivalent nicotine products per day within 3 months, or those who were unable to ban smoking during the trial period, or those who were positive in smoking test; 12. Patients with drug abuse / contraband drugs and those with positive drug screening in urine during screening period; 13. Patients who have used any drugs within 2 weeks (including traditional Chinese medicine and over-the-counter drugs); 14. Hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody and human immunodeficiency virus antibody were positive; 15. Patients with abnormal laboratory examination and judged as clinically significant by the researchers (among them, the serum creatinine and urea must be within the reference value range); 16. Patients with glomerular filtration rate (EGFR) < 90 mL / min / 1.73 M2 (EGFR was estimated by CKD-EPI formula); 17. Patients with poor vascular conditions and unable to accept intravenous administration; 18. Immediate family members of the staff involved in the clinical study; 19. The researcher judged that other situations were not suitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;pharmacokinetic/ pharmacodynamic index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed