Respiratory infections, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections
Conditions
Interventions
Group A of single dose:cefotaxime sodium and tazobactam sodium(T)1g-T2g-cefotaxime sodium(R)4g-T4g
Group B of single dose:T2g-T4g-T1g-R4g
Group C of single dose:T4g-R4g-T2g-T1g
Group D of single dose:R4g-T1g-T4g-T2g
Multiple dose group:T3g, ivgtt, bid, 9 times
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following conditions will ba allowed to the trial 1) Aged = 18 years, male and female; 2) The weight of male subjects is =50.0 kg, the weight of female subjects is =45.0 kg, and the body mass index (BMI) is between 19 and 26 kg/m2, including the boundary value; 3) Subjects (including male subjects) are willing to take effective pregnancy measures from the screening date to the 6 months after the end of the time without a pregnancy plan; 4) Subjects voluntarily sign written informed consent; 5) Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: Subjects who meet one of the following conditions will not be eligible for the trial. 1) Any clinically serious disease, such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other disease that can interfere with the test results; 2) A history of allergies to drugs, food or other substances; 3) Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study; 4) Those who have taken any drugs (including vitamins and Chinese herbal medicines) within 14 days before the test; 5) Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; 6) Any clinical trial drug or any clinical trial of the drug within 3 months prior to the trial; 7) Donoring blood or a large amount of blood loss (=200 mL) within 3 months before the test, receiving blood transfusion or using blood products; 8) Women who are pregnant or lactating, or who cannot take one or more contraceptive measures during the trial; 9) Those who have special requirements for diet and cannot follow the unified diet; 10) Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 11) smokers or more than 5 cigarettes per day for the first 3 months of the trial; 12) Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 13) Drug abusers or those who have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 14) Patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or drug skin test, imaging examination, physical examination, electrocardiogram, Laboratory abnormalities have clinical significance (subject to the judgment of the clinician); 15) Those who cannot tolerate venipuncture, and/or those with a history of fainting halo; 16) Abnormal alcohol breath test (>0 mg/mL); 17) Subjects may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Cefotaxime;Plasma concentration of Tazobactam;Urine concentration of Cefotaxime;Urine concentration of Tazobactam; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed