Bioequivalence study
Conditions
Interventions
Sponsors
Jilin University First Hospital Drug Clinical Trial Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2. able to complete the study according to the test plan requirements; 3. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before the drug administration to the last 6 months after the last study drug administration. See Appendix 5 for specific contraceptive measures; 4. Male and female subjects aged 18-50 years (including 18 and 50 years old); 5. Male subjects weigh no less than 50 kg and female subjects weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index in the range of 18 ~ 28kg / m2 (including the critical value); 6. Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. More than 5 cigarettes per day for 3 months before the trial; 2. Allergic history of test drugs, allergies (multiple drugs and food allergies); 3. Have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; 4. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 5. Donate blood or massive blood loss (>450 mL) within the first three months of screening; 6. Take any drug that changes liver enzyme activity 28 days before screening; 7. Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days of screening; 8. Take a special diet (such as grapefruit) within 2 weeks before screening or have strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc.; 9. Recently there have been major changes in diet or exercise habits; 10. took the research drug or participated in the drug clinical trial within three months before taking the study drug; 11. dysphagia or any history of gastrointestinal disease affecting drug absorption; 12. suffering from any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers, etc.; 13. Patients with blood system diseases such as coagulopathy; 14. ECG abnormalities have clinical significance; 15. Female subjects are in lactation or positive for serum pregnancy during the screening period or during the trial; 16. Clinical laboratory tests have the following clinically significant abnormalities, or other clinical findings that have clinical significance (including but not limited to the gastrointestinal tract, kidney, liver, nerves, blood, endocrine, tumor, lung, immune, mental or mental and brain) Vascular disease); 17. Viral hepatitis (including hepatitis B and hepatitis C), HIV antibody, and Treponema pallidum antibody screening positive; 18. Acute disease or concomitant medication from the screening stage to the study before administration; 19. Ingested chocolate, any caffeine-containing or jaundice-rich food or drink 48 hours before taking the study drug; 20. Have taken any alcoholic products within 48 hours before taking the study medication; 21. urinary sieve-positive people or a history of drug abuse in the past five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC-8;Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactGuocheng Zhang
the First Hospital of Jilin University
Outcome results
None listed