This product is suitable for the infections caused by sensitive bacteria
Conditions
Interventions
Fasting study:a single oral dos
Feding study:a single oral dos
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects who signed the informed consent before the trial, and fully understood the trial content, process and possible adverse reactions; 2. The subjects who can complete the study according to the requirements of the trial protocol; 3. The subjects (including their partners) had no pregnancy plan and voluntarily took effective contraceptive measures from 2 weeks before self-sufficiency to 6 months after the last study drug administration. The specific contraceptive measures are shown in Appendix 5; 4. Male and female subjects aged from 18 to 45 (including 18 and 45 years old); 5. The weight of male subjects is not less than 50kg, and that of female subjects is not less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), body mass index in the range of 18-26 kg / m2 (including the critical value); 6. Subjects with normal or abnormal physical examination and vital signs without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Patients with clinically significant hematology, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, mental, nervous system diseases or abnormal clinical laboratory examination during screening; 2. Evidence or history of patients with allergic diseases (including drug allergy, such as azithromycin, erythromycin, other macrolides or ketolides, allergic constitution (multiple drug and food allergy), but excluding asymptomatic seasonal allergy not treated at the time of administration); 3. Patients who smoked more than 5 cigarettes per day in 3 months before the trial; 4. The current or past history of alcoholism (drinking 14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or 100ml of wine) or those who could not abstain during the experiment; 5. Patients who donated blood or lost a large amount of blood (> 450ml) within three months before screening, those who received blood transfusion and used blood products; 6. Patients with positive results of urine drug screening or drug abuse history in the past five years; 7. Patients with ECG abnormalities of clinical significance, including but not limited to patients with known QT prolongation and clinical significance, history of torsade de pointe, congenital QT prolongation syndrome and decompensated heart failure; 8. Patients with other acute or chronic medical or mental diseases, including recent (past year) or active suicidal ideation or behavior, may increase the risk associated with participating in the study or drug administration, or may interfere with the interpretation of the study results; 9. Patients with dysphagia or any history of gastrointestinal diseases affecting drug absorption; 10. Patients who took any drugs that changed liver enzyme and / or transporter activities or interacted with azithromycin (such as erythromycin, verapamil, digoxin, diclofenac sodium, indomethacin, antacids, zidovudine, atorvastatin, cimetidine, coumarin, cyclosporin, fluconazole, ergotamine or dihydroergotamine, etc.) 28 days before screening; 11. Subjects who took any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening; 12. The subjects who had taken special diet (including apple, pomegranate, pineapple, pitaya, mango, grapefruit, grapefruit, citrus, carambola, mulberry, peanut, tea, etc.) within 14 days before taking the study drug or who could not stop eating during the experiment, or had strenuous exercise, or other factors affecting the absorption, distribution, metabolism and excretion of the drug; 13. Subjects who took the study drug or participated in the clinical trial of the drug within three months before taking the study drug; 14. Objects who have special dietary requirements and can't follow the same diet (such as intolerance to standard food and lactose, etc.); 15. Female subjects in the screening period or in the course of the test are in lactation or serum pregnancy test results are positive; 16. Patients with viral hepatitis (including hepatitis B and hepatitis C), HIV antigen / antibody and Treponema pallidum antibody were screened positive; 17. Patients with acute diseases or significant changes in medication, diet and exercise habits from the screening stage to before taking the study drug; 18. Patients who ingested chocolate, any caffeinated, poppy or xanthine rich food or drink (such as coffee, strong tea, cola, red bull, etc.) 48 hours before taking the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equivalence criteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation criteria; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed