None listed
Conditions
Interventions
Fasting administration group:Group 1:R-R-T
Group 3:T-R-R
Postprandial administration group 1:Group 1:R-R-T
Postprandial administration group 2:Group 1:R-R-T
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 18 to 55 years, both men and women; 2. Male subjects weigh no less than 50 kg, female subjects weigh no less than 45 kg; body mass index (BMI) ranges from 19 to 28 kg/m2 (including cut-off values); 3. Subjects are healthy, no history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic diseases; 4. Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions. Volunteers are able to communicate well with researchers.
Exclusion criteria
Exclusion criteria: 1. Participate in any clinical trial within 90 days before the trial, or plan to participate in other clinical trials during the research period; 2. Have received major surgery within 90 days before the test or plan to undergo surgery within 3 months after the administration; 3. Blood loss or donation of more than 300mL within 90 days before the test (excluding blood loss during menstrual period), or received blood transfusion; 4. Suffered from esophageal reflux, stomach bleeding or peptic ulcer disease within 180 days before the test, heartburn occurred more than once a week, or any surgical operation (such as cholecystectomy) that may affect drug absorption; 5. People who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic physiques (such as those who are allergic to two or more drugs, food and pollen), or are known to be cephalosporins, penicillins, and this drug Component* or similar allergy; 6. Use any drugs within 28 days before the test, including the use of prescription drugs, over-the-counter drugs and/or alternative drugs (such as medicated diet, Chinese herbal medicine, hemostatic and blood-activating plants or health products), and the use of hormonal contraception or vaccines; 7. There is a history of psychotropic substance abuse; 8. Urine drug screening is positive; 9. The penicillin skin allergy test is positive; 10. On average, smoked more than 5 cigarettes a day in the 90 days before the test; addicted to alcohol, in the 28 days before the test, women drank more than 7 glasses per week or men drank more than 14 glasses per week (1 cup=150mL wine=360mL beer=45mL spirits) 11. Alcohol breath test is positive; 12. Body temperature (ear temperature) >=37.5?, breathing is obviously abnormal and the researcher thinks it is not suitable to participate in the test, sitting systolic blood pressure>140mmHg or 90mmHg or 100 times/min; 13. There are special requirements for diet, and the uniform diet cannot be observed during the test period; 14. The subject refused to comply with the ban on beverages and foods containing caffeine, alcohol, and grapefruit (including tea, chocolate, coffee, cola, etc.) 48 hours before taking the drug; 15. Subjects with partners refuse to use effective contraceptive measures within 180 days from screening to the end of the study; 16. The pregnancy test of female subjects is positive; 17. There are obvious abnormalities in the physical examination and the researcher believes that it is not suitable to participate in the trial; 18. There are obvious abnormalities in the ECG examination and the researcher thinks it is not suitable to participate in the trial; 19. There are obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations, and the researcher thinks it is not suitable for participating in the test; 20. Dizziness of needles, dizziness of blood and difficulty in venous blood collection; 21. Have a history of jaundice or liver damage related to amoxicillin/clavulanic acid; 22. Subjects may not be able to complete this study due to other reasons or other researchers judged to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;The area under the medicine-time curve from zero to t;The area under the medicine-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactJin Feiyan
Dongyang Hengdian Hospital
Outcome results
None listed