Mild to moderate infections caused by specified microbial sensitive strains in the following specific diseases.
Conditions
Interventions
Fasting - TRR Group:Phase 1: Receive a single oral dose of 250 mg generic Azithromycin tablets
Phase 2: Receive the control drug Zithromax? Azithromycin tablets
Phase 3: Again receive the control drug Zithromax? Azithromycin tablets.
Postprandial - TRR Group:Phase 1: Receive a single oral dose of 250 mg generic Azithromycin tablets
Postprandial - RRT Group:Phase 1: Receive the control drug Zithromax? Azithromycin tablets
Phase 2: Again receive the control drug Zithromax? Azithromycin tablets
Phase 3: Receive the trial drug with a single oral dose of 250 mg generic Azithromycin tablets.
Postprandial - RTR Group:Phase 1: Receive the control drug Zithromax? Azithromycin tablets
Phase 2: Receive the experimental drug a single oral dose of 250 mg generic Azithromycin tablets
Phase 3: Receive the control drug Zithromax? Azithromycin tablets
Fasting - RRT Group:Phase 1: Receive the control drug Zithromax? Azithromycin tablets
Fasting - RTR Group:Phase 1: Receive the control drug Zithromax? Azithromycin tablets
Sponsors
Luoyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Gender: Male and female subjects; 2) Age: 18 years and older (inclusive of 18 years); 3) Weight: Male subjects should weigh no less than 50.0 kg, female subjects should weigh no less than 45.0 kg, and Body Mass Index [BMI = weight(kg)/height^2(m^2)] should be within the range of 19.0 to 26.0 kg/m^2 (including boundary values); 4) Health verified through medical history inquiry, physical examination, and laboratory tests; 5) Participants must voluntarily participate and sign an informed consent form; the process of obtaining informed consent must comply with GCP; 6) Subjects must be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1) Vital signs examination, physical examination, 12-lead electrocardiogram, clinical laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, Hepatitis B five-item test, blood three tests), pregnancy examination (for females) judged clinically significant by the investigator; 2) History of chronic diseases or severe diseases in the liver, kidney, digestive system, endocrine system, cardiovascular system, nervous system, metabolic system, hematologic system, respiratory system, and autoimmune system, or current existence of diseases in the aforementioned systems, deemed unsuitable for enrollment by the investigator; 3) History of cholestatic jaundice/liver dysfunction after previous use of azithromycin; 4) Patients with a known history of QT interval prolongation, Torsades de Pointes ventricular tachycardia, congenital long QT syndrome, bradyarrhythmias, or decompensated heart failure; 5) History of dizziness upon waking or history of syncope; 6) Allergy history, such as allergies to drugs or food; or known allergy history to the components of this drug; 7) History of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (had previously experienced diarrhea after drinking milk); 8) Individuals with special dietary requirements who cannot adhere to a standardized diet; or those with swallowing difficulties; 9) Those who cannot tolerate venous catheter blood draws or experience needle phobia or blood phobia; 10) Individuals who have undergone major surgery within the 3 months prior to screening, or who plan to undergo surgery during the trial, or who have had surgeries that could affect drug absorption, distribution, metabolism, or excretion; 11) Individuals who have averaged more than 14 units of alcohol per week (1 unit ˜ 360 mL of beer with 5% alcohol, or 45 mL of liquor with 40% alcohol, or 150 mL of wine with 12% alcohol) in the 3 months prior to screening, or who cannot stop using any alcoholic products during the trial; 12) Individuals who have donated blood or experienced significant blood loss (>400 mL, excluding menstrual blood loss) in the 3 months prior to screening, or who plan to donate blood during or within 1 month after the trial; 13) Individuals who have consumed excessive amounts (averaging more than 8 cups per day, where 1 cup = 250 mL) of tea, coffee, or caffeinated beverages in the 3 months prior to screening; or those who have consumed tea or any caffeinated foods or beverages (such as coffee, chocolate, etc.) within 48 hours prior to the first administration; 14) Individuals who smoke more than 5 cigarettes on average per day in the 3 months prior to screening, or who cannot stop using any tobacco products during the trial; 15) Individuals who have participated in other clinical trials and taken the study drug within the last 3 months prior to screening; 16) Individuals who have received a vaccine within the last 1 month prior to screening, or those who plan to receive a vaccine during the study; 17) Individuals who have taken any drug that interacts with azithromycin (such as nelfinavir, macrolides, and antacids containing aluminum or magnesium, etc.) or any drugs that inhibit or induce hepatic drug metabolism (such as inducers—barbiturates, carbamazepine, phenytoin, corticosteroids, omeprazole; inhibitors—SSRIs, cimetidine, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;Cmax; | — |
Countries
China
Contacts
Public ContactZhu Shaofeng
Luoyang Central Hospital
Outcome results
None listed