None listed
Conditions
Interventions
Fasting Group A (T-R):In the fasting state, the subjects took the test preparation piperoxili in the first cycle
The operation of the second cycle was the same as before, and piperoxicillin reference preparation was taken.
Fasting Group A (R-T):In the fasting state, the subjects took piperacillin reference preparation in the first cycle
The second cycle operation was the same as before, and piperoxil was administered.
Feding Group A (T-R):In the postprandial state, the subjects took the test preparation piperoxili. in the first cycle
The operation of the second cycle was the same as before, and piperoxicillin reference preparation was taken
Feding Group B (R-T):In the postprandial state, the subjects took piperacillin reference preparation in the first cycle
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All the entry criteria must be met: 1) The subject fully understands the purpose, nature, method and possible adverse reactions of the experiment, voluntarily acts as a subject, and signs informed consent prior to the commencement of any research procedure; 2) Male and female subjects >=18 years of age, the proportion of single-sex subjects is appropriate; 3) Male weight >=50.0 kg, female weight >= 45.0kg; Body mass index (BMI) in the range of 19.0 to 26.0 kg/m^2 (BMI= weight (kg)/height ^2 (m^2), including the critical value); 4) The subject has no history of chronic or serious diseases of cardiovascular, digestive, urinary, respiratory, blood and lymphatic, endocrine, immune, psychiatric, nervous, skin and skeletal systems (consultation); 5) The subjects (including male subjects) had no pregnancy plan from 1 month before screening to 6 months after the last administration of the study drug, voluntarily adopted effective contraceptive measures (see Appendix 2 for specific contraceptive measures), and had no sperm or egg donation plans; 6) Subjects voluntarily sign informed consent, communicate well with researchers, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Exclusion is defined if one of the following exclusion criteria is met:1) Patients with dysphagia; 2) Have any history of surgery or trauma that may affect the safety of the trial or the process of drug metabolism in the body, or have undergone surgery that may affect drug absorption, distribution, metabolism or excretion in the 3 months prior to screening, or plan to undergo surgery during the study period; 3) Patients who cannot tolerate venipunction or have a history of needle faintness or blood collection difficulty; 4) Those who have used drugs in the past 3 months or have a history of drug abuse in the past 3 years or have positive urine drug screening; 5) Patients who have taken clinical research drugs or participated in clinical trials in person within 3 months before screening; 6) Patients who donated or lost more than 400 mL of blood within 3 months before screening, received blood transfusion or used blood products; 7) Female subjects who are lactating or have positive pregnancy test results during the screening period or during the test; 8) Those who have taken any drug that alters liver enzyme activity or interacts with piperoxil (CYP3A inhibitors and inducers (e.g. Clarithromycin, indinavir, itraconazole, ketoconazole, Lopinavir/Ritonavir, Nefazodone, Nefinavir, Posaconazole, saquinavir, Terrapivir, teliomycin, voriconazole; Carbamazepine, enzalutamide, phenytoin, rifampin containing St. John's Wort)); 9) Those who have taken any drugs or health products within 2 weeks before screening; 10) Have a history of drug, food allergy or allergic constitution; 11) Those who smoked more than 5 cigarettes per day in the 3 months before screening or could not stop using any tobacco products during the test; 12) Those who consumed more than 14 units of alcohol per week (1 unit ˜357 mL beer or 43 mL liquor with 40% alcohol or 147 mL wine with 12% alcohol) in the three months prior to screening, or whose alcohol breath test results were greater than 0mg/100ml, or who could not abstain during the test period; 13) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) per day in the 3 months prior to screening; 14) Those who received any vaccine within half a month before screening; 15) Those who are lactose intolerant or have special requirements for diet and cannot accept a unified diet; 16) Laboratory examination (blood analysis, urine analysis + urine sediment quantification, blood biochemistry, blood coagulation, hepatitis B, hepatitis C HIV syphilis examination, blood pregnancy examination (female)), vital signs examination, physical examination, 12-lead electrocardiogram, chest X-ray examination abnormal clinical significance; 17) Those who had consumed fruits or related products (such as grapefruit, pomelo, dragon fruit, mango) that affected drug metabolism within 3 days before administration, or who could not stop eating the above special diet during the trial; 18) Within 48 hours before taking the study drug: patients who suffered from diseases, took drugs and were determined by the researcher to be unable to be enrolled; People who have consumed chocolate, any food or drink containing caffeine or xanthine; 19) Other investigators determine that the subject is not fit to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;Area under the drug time curve from time 0 to time t;The area under the medicinal time curve from time 0 to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Elimination of terminal half-life;Peak time; | — |
Countries
China
Contacts
Public ContactDong Zhanjun
Hebei General Hospital
Outcome results
None listed