Antibacterial treatment
Conditions
Interventions
Sponsors
Huzhou Central Hospital, Zhejiang Province
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 test, and voluntarily acts as a subject, and sign an informed consent form before any research procedure begins; 2. Male and female subjects aged 18 to 65 years (including 18 and 65 years); 3. Male weight = 50.0 kg, female weight = 45.0 kg, body mass index (BMI) between 19.0 and 26.0 kg/m2 (including critical values); 4. The subject has no history of chronic or serious diseases such as cardiovascular, liver, kidney, blood and lymph, endocrine, immune, mental, neurological, or gastrointestinal system, and overall good health; 5. Vital sign examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infection disease screening, coagulation function, pregnancy test (female), 12-lead electrocardiogram, urine drug screening and alcohol breath test, the result shows no abnormality or no clinical significance; Those who do not meet one of the above conditions shall not be selected as voluntary subjects.
Exclusion criteria
Exclusion criteria: 1. Persons who have a history of allergy to azithromycin and any drug component of azithromycin tablets, or are known to be allergic to erythromycin, macrolides, and ketolactones, or have experienced allergies to two or more drugs or foods; 2. Have a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption; 3. Those who have experienced clinically significant diseases such as arthralgia, urticaria, angioneurotic edema, or any diseases that increase the risk of bleeding (such as intracranial hemorrhage, gastrointestinal bleeding or perforation, clinically significant thrombocytopenia, coagulation dysfunction, etc.); 4. Any person with a history of surgery or trauma that has been determined by the research doctor to be clinically significant and may affect the safety of the trial or the metabolic process of the drug in vivo, or who plans to undergo surgery during the trial period (from signing the informed consent form to discharge in the third cycle); 5. Those who have used any drugs (including prescription drugs, non prescription drugs, Chinese herbal medicines, etc.) or health products within 2 weeks before screening; 6. Those who have received vaccine within 30 days before screening; 7. Have used any drugs that inhibit/induce liver metabolism of drugs within 30 days before screening (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); Or any drug that alters the gastrointestinal environment (such as proton pump inhibitors such as tetoprazole, omeprazole, lansoprazole, esomeprazole, etc.; H2 antagonists ranitidine, cimetidine, famotidine, etc.; antacid agents such as sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc.; gastric mucosal protective agent sucralfate, etc.); Or any drug that has drug interactions with this product; 8. Screening for persons with a history of drug abuse within the previous 6 months; 9. Screening for those who have used drugs within the previous 6 months; 10. Those who smoke more than 5 cigarettes per day within 3 months before screening, or who do not agree to stop smoking or consume any food containing tobacco during the trial period (from signing the informed consent form to discharge in the third cycle); 11. Those who drink more than 14 units (1 unit=17.7mL ethanol, that is, 1 unit=357mL beer with 5% alcohol, 43mL Baijiu with 40% alcohol, or 147mL wine with 12% alcohol) per week within 3 months before screening, or do not agree to stop drinking or eat any alcoholic food during the test period (from signing the informed consent form to discharge in the third cycle); 12. Those who consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup=250 ml) every day within 3 months before screening, or who did not agree to stop consuming tea, coffee, and/or caffeine-rich foods or beverages (including chocolate, cola, etc.) during the trial period (from signing the informed consent form to discharge in the third cycle); 13. Those who have taken foods containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, grapefruit, lime, etc.) and prepared foods or beverages within 7 days before the start of the trial, or who do not agree to stop eating such foods during the trial period (from signing the informed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed