None
Conditions
Interventions
TR group:In the first period, take 1 tablet of the test preparation on fasting or fed condition
in the second period, take 1 tablet of the reference preparation on on fasting or fed condition.
RT group:In the first cycle, take 1 tablet of the reference preparation on fasting or fed condition
in the second cycle, take 1 tablet of the test preparation on fasting or fed condition.
Sponsors
Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria of healthy subjects must meet the following criteria: 1.Subjects who are capable of understanding and willing to strictly adhere to the clinical trial protocol and sign the informed consent form.; 2. Male and female subjects aged 18 to 65 years (including the boundary values); 3.Male subjects with a weight of =50.0 kg, and female subjects with a weight of =45.0 kg; Body Mass Index (BMI) within the range of 19.0 to 26.0 kg/m2 (including the critical values); 4.Subjects in good health, with no history of serious or chronic diseases of the respiratory, circulatory, digestive, urinary, hematopoietic, endocrine, immune, nervous, or psychiatric systems. 5) Subjects (including their partners) must not plan to become pregnant within 2 weeks prior to the screening period and up to 3 months after the last administration of the study medication, and must ensure the use of appropriate contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Known allergies to two or more drugs or foods, or a history of allergy to any component of sitafloxacin or other quinolone antimicrobials; 2. Difficulty swallowing tablets; 3.Special dietary requirements that cannot accept uniform diet; 4.Intolerance to venous puncture, with a history of fainting from needles or blood; 5. Abnormalities in physical examination, vital signs, ECG, abdominal ultrasound, chest X-ray, and other clinically significant findings as judged by the investigator; 6.History of any serious clinical diseases, including but not limited to cardiovascular, respiratory, digestive, endocrine, and neuropsychiatric systems (including epilepsy); 7.Abnormal laboratory test results (such as creatine kinase > 1.5 times the upper limit of normal, alanine aminotransferase, aspartate aminotransferase > 1.2 times the upper limit of normal, creatinine > upper limit of normal) with clinical significance; 8. History of joint diseases, myopathies, tendinitis, tendon rupture, muscle weakness, rhabdomyolysis, and history of muscle or tendon injuries; 9. History of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmias, ventricular tachycardia, QT prolongation syndrome, or family history (with genetic proof or close relatives dying at a young age due to cardiac causes); 10. Any clinically significant abnormalities in hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis spirochete antibody; 11.Regular alcohol consumption in the past 6 months, i.e., more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL of liquor with 40% alcohol or 150mL wine); 12.Blood donation or significant blood loss (>400mL) within 3 months before screening; 13.Smoking =5 cigarettes per day within 3 months before screening; 14.Use of study medication or participation in any clinical trial within 3 months before screening; 15. Received surgical procedures within 30 days before admission, or planning to undergo surgery during the study period; 16.Use of any prescription drugs, over-the-counter drugs, health products, vitamins, or Chinese herbal medicines within 14 days before admission; 17.Use of grapefruit, pomelo, dragon fruit, mango, or related products that affect metabolic enzymes within 7 days before admission; 18.Excessive consumption (more than 8 cups per day, 1 cup = 250mL) of tea, coffee, or caffeine-containing beverages, or intake of chocolate, any food containing caffeine or rich in xanthine components within 48 hours before admission; 19. Consumption of any alcohol-containing products within 48 hours before admission, or positive alcohol breath test results; 20.Female subjects who are breastfeeding or have a positive blood pregnancy test; 21. History of drug abuse or positive urine drug screening; 22.Acute diseases occurring from the screening stage to before dosing; 23.Subjects whom the investigator deems should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;Area under the curve in the time from administration to the lowest detectable blood concentration;Area under the curve from administration to extrapolation to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration;Plasma elimination half-life; | — |
Countries
China
Contacts
Public ContactDong Liu; Guang Du
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Outcome results
None listed