Strep throat, tonsillitis (including peritonsillitis, peritonsillar abscess), acute bronchitis, pneumonia, lung abscess, otitis media.
Conditions
Interventions
Fasting T-R group:Randomly assigned, the first cycle took the test preparation, the second cycle took the reference preparation, and 4ml of upper extremity venous blood was collected at a total of 23
Fasting R-T group:Randomly assigned, the first cycle took the reference preparation, the second cycle took the test preparation, and 4ml of upper extremity venous blood was collected at a total of 23
Postprandial T-R group:Randomly assigned, the first cycle took the test preparation, the second cycle took the reference preparation, and 4ml of upper extremity venous blood was collected at a total o
Postprandial R-T group:Randomly assigned, the first cycle took the reference preparation, the second cycle took the test preparation, and 4ml of upper extremity venous blood was collected at a total o
Sponsors
Panyu District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form before the start of any research procedure; 2. Men and women aged 18-65 (including 18 and 65 years old) with an appropriate sex ratio; 3. Male weight= 50.0 kg, female weight = 45.0 kg; Body mass index (BMI) in the range of 18.5~26.0 kg/m2 (including critical value), BMI = body weight (kg) / height (m) 2; 4. Vital sign examination, physical examination, clinical laboratory examination (blood routine, urine routine analysis, blood biochemistry, blood transfusion, coagulation function, pregnancy test (women), drug screening, etc.), 12-lead ECG results show no abnormality or abnormal and no clinical significance; 5. No pregnancy plan during the screening period and the next 3 months and voluntary use of effective contraceptive measures (Appendix 2) and no sperm or egg donation plan; 6. Able to communicate well with the researcher, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution (such as allergic to two or more drugs, food or pollen), known to be allergic to azithromycin, erythromycin or other macrolides. cholestatic jaundice/hepatic insufficiency after previous azithromycin use; 2. Those with a history of gastrointestinal diseases (including existing) within 3 years, including chronic or active upper gastrointestinal diseases such as dysphagia, esophageal diseases, gastritis, duodenitis, ulcers, peptic ulcers or active gastrointestinal bleeding or gastrointestinal surgery; 3. Those with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, respiratory system, digestive system, urinary system, immune system, kidney, liver or metabolic disorders or psychiatric diseases; 4. Have used any drug within 2 weeks before the first dose of the test drug; 5. Screening of those who have been vaccinated within 4 weeks before or who plan to be vaccinated during the study period; 6. Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study; 7. Those who have participated in or are participating in other drug clinical trials within 3 months before screening; 8. Those who have donated blood within 3 months before screening, and the sum of blood donation or blood loss due to other reasons within 3 months reaches or exceeds 400mL (except for female menstrual blood loss); 9. Those who have drinking habits (drinking more than 14 units of alcohol per week for 3 months before the test or an average of more than 2 units of alcohol per day, 1 unit = 360mL of beer or 150mL of wine or 45mL of liquor) or those who have a positive breathalyzer test or do not agree to avoid drinking during the test; 10. Those who drank excessive strong tea, coffee or caffeinated beverages every day within 3 months before screening (more than 8 cups a day, 1 cup = 250mL); 11. Within 48 hours before taking the drug, ingest any food (such as chocolate) and beverages (such as tea, coffee, cola, etc.), grapefruit juice, etc. containing alcohol or xanthine compounds; 12. Those who smoke more than 5 cigarettes per day within 3 months of the screening period, or cannot stop using any tobacco products during the trial period; 13. Those who used drugs (such as: morphine, methamphetamine (methamphetamine), ketamine, ecstasy (methylenedioxyamphetamine), marijuana (tetrahydrocannabinolic acid, etc.) or drug screening positive in the 3 months before screening; 14. Those who have special requirements for diet and cannot accept a unified diet (such as unable to tolerate milk, eggs, butter, bacon and other foods); 15. Human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, treponemal antibody (Anti-TP) any one or more test results are positive; 16. Difficulty in venous blood collection, or inability to tolerate venous puncture, or history of needle sickness; 17. Acute diseases occur in the pre-study screening stage or before the study drug is judged by the investigator to have clinical significance; 18. Subjects judged by other investigators to be unsuitable to participate in this clinical study; In addition to the above requirements, female subjects who meet the following conditions should also be excluded: 19. Those who used oral contraceptives within 30 days before the trial; 20. Women of childbearing age who have non-prot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu District Central Hospital
Outcome results
None listed