Throat, tonsillitis (including peritonsillitis, peritonsillitis abscess), acute bronchitis, pneumonia, lung abscess Swelling, otitis media)
Conditions
Interventions
Group B after meal:Take the reference preparation in the first cycle and the test preparation in the second cycle
Group A after meal:Take the reference preparation in the first cycle and the test preparation in the second cycle
Sponsors
Panyu District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers fully understand the purpose, nature, method and possible adverse reactions of the experiment, volunteer to be a volunteer, and sign informed consent prior to the start of any study procedure; 2. Males and females aged 18-65 (including 18 and 65) with appropriate sex ratio; 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; Body mass index (BMI) was in the range of 18.5~26.0 kg/m2 (including the critical value), BMI= weight (kg)/height (m) 2; 4. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine analysis, blood biochemistry, blood transfusion four items, coagulation function, pregnancy test (female), drug screening, etc.), 12 lead electrocardiogram results show no abnormalities or abnormalities have no clinical significance; 5. During the screening period and in the next 3 months, he/she has no pregnancy plan, voluntarily takes effective contraceptive measures and has no sperm or egg donation plan; 6. Be able to communicate well with researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution (such as allergic to two or more drugs, food or pollen), known allergic to azithromycin, erythromycin or other macrolides. Cholestatic jaundice/liver insufficiency after previous use of azithromycin; 2. Patients with a history of gastrointestinal diseases (including existing ones) within 3 years, including chronic or active upper gastrointestinal diseases such as dysphagia, esophageal diseases, gastritis, duodenitis, ulcers, gastrointestinal ulcers or active gastrointestinal bleeding or gastrointestinal surgery; 3. Diseases 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 mental system diseases; 4. Have used any drug within 2 weeks before the first dose of the test drug; 5. Those who received COVID-19 vaccine less than 4 weeks before screening, or received other vaccines within 3 months, or planned to receive vaccines during the trial; 6. Had surgery within 3 months prior to screening, or planned to have surgery during the study period; 7. Participants 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 whose total blood loss from blood donation or other reasons within 3 months reaches or exceeds 400mL (except blood loss during menstrual period for female); 9. Those who had a drinking habit (more than 14 units of alcohol per week or an average of more than 2 units of alcohol per day (alcohol volume (g) = alcohol content x ml x 0.8), 1 unit = 360 mL beer or 150 mL wine or 45 mL liquor in the 3 months before the test) or tested positive or did not agree to avoid drinking alcohol during the test; 10. Those who consumed excessive strong tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 250 mL) in the previous 3 months; 11. Consume any strong tea, chocolate, coffee or food or drink containing caffeine, xanthine (e.g., anchovies, sardines, beef liver, kidney, etc.), alcohol, grapefruit (juice) or grapefruit (juice) within 48 hours before taking the medication; 12. Smokers who smoked more than 5 cigarettes per day within 3 months during the screening period, or who could not stop using any tobacco products during the test period; 13. Use of drugs (e.g., morphine, methamphetamine (methamphetamine), ketamine, ecstasy (dimethylene dioxyamphetamine), cannabis (tetrahydrocannabinol), etc.) or positive drugs in the 3 months prior to screening; 14. Those who have special dietary requirements and cannot accept uniform diet (such as intolerance of 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, treponema pallidum antibody (Anti-TP) any one or more test results positive; 16. Difficulty in venous blood collection, inability to tolerate venipunction, or a history of fainting needle and fainting blood; 17. Patients who developed acute diseases at the pre-study screening stage or before the study medication and were judged by the investigators to be clinically significant; 18. Volunteers who are judged unsuitable for this clinical study by other researchers; In addition to the above requirements, female volunteers who meet the following conditions s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of azithromycin granules; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;adverse event;adverse event; | — |
Countries
China
Contacts
Public ContactFu Xihua
Panyu District Central Hospital
Outcome results
None listed