Equivalence study
Conditions
Interventions
Two groups:Dosing sequence
Sponsors
Changsha Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Fully understand the purpose and requirements of this test, voluntarily participate in this test, follow the research requirements according to the test requirements, and sign the informed consent form according to the relevant provisions of the GCP; (2) Volunteers aged = 18 years old, both men and women; (3) Body weight index: the subject's weight = 50 kg, body mass index (BMI) = 19.0 kg/m2 and = 26.0 kg/m2. The body mass index is calculated as follows: body mass index (BMI) = body weight (kg) / square of height (m2); (4) Volunteers are able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. (screening period / check-in) any one has been or is currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, and researchers believe that have clinical significance or can interfere with the results of this test; 2. (diagnosis during screening period) The investigator judged that the subject had an increased risk of bleeding, such as: (1) bleeding disorders (habitual bleeding gums, etc.); (2) blood in the stool (active acne, etc.); (3) Injecting a trauma or surgery with a persistent bleeding risk within the previous month, or having a surgical plan within 6 months of participating in the trial; (4) history of arteriovenous malformations or aneurysms; (5) Gastroduodenal ulcer disease; (6) history of intracranial, intraocular, spinal cord, retroperitoneal or noninvasive intra-articular hemorrhage; (7) history of gastrointestinal related surgery; (8) familial early onset cerebral hemorrhage; 3. (diagnosis during the screening period) There is a history of allergies or allergies of food drugs that the researcher has determined to be clinically significant; 4. (diagnosis during the screening period) who have a history of fainting or fainting or who cannot tolerate venipuncture; 5. (screening period / check-in) Use drugs that may affect the test results, especially P-gp, inhibitors or inducers, within four weeks of the study screening or during the test period.(P-gp inducers such as rifampicin, CYP3A4 inhibitors such as azole antifungal agents, macrolides or grapefruit juice, CYP3A inducers such as St. John's wort or certain anticonvulsants); 6. (screening period / check-in consultation) Take drugs that affect blood coagulation within 30 days before the screening or during the test period, namely acetylsalicylic acid, non-steroidal antirheumatic drugs, coumarin and the like; 7. (diagnosis during screening period) The study was vaccinated within 3 months prior to screening. 8. (screening period / check-in) Those who took any drug within 14 days before the test (including Chinese herbal medicine); 9. (screening period consultation / network screening) participated in any drug clinical trial within 3 months before the trial; 10. (screening period / check-in consultation) Study blood loss = 200ml within 3 months before screening (except for female physiological period), or plan to donate blood or blood components during the study period or within 3 months after the end of the study; 11. (screening period/check-in) Male subjects (or their partners) or female subjects have unprotected sexual behavior or pregnancy plans from 2 weeks before screening to 3 months after the end of the trial. Reluctance to take one or more non-pharmacological contraceptives (such as complete abstinence, contraceptive ring, partner ligation, etc.); 12. (in the screening period) drug abusers or soft drugs (such as: marijuana) 3 months before the test or 1 year before the test, such as cocaine, phencyclidine, etc.; 13. (diagnosis during screening) has special requirements for diet, can not comply with the unified diet, or lactose intolerance, or significantly abnormal / special diet (such as diet, low sodium diet) 4 weeks before screening ); 14. (screening period / check-in) smokers or more than 5 cigarettes per day for the first 3 months of the trial or those who are unwilling to stop using tobacco products during the trial p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLi Xin
Changsha Third Hospital
Outcome results
None listed