None
Conditions
Interventions
Group A (T-R-T-R):One tablet of the test preparation was taken orally on an empty stomach in the first cycle, one tablet of the reference preparation in the second cycle, one tablet of the test prepar
Group B (R-T-R-T):One tablet of reference preparation was taken orally in the first cycle, one tablet of test preparation was taken orally in the second cycle, one tablet of reference preparation was
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Healthy subjects over 18 years old (including 18 years old), both male and female; 2) Weight =50.0kg, and body mass index (BMI) is in the range of 19.0 to 26.0kg/m2 (including 19.0 and 26.0) (BMI= weight/height 2); 3) No birth plan within 1 month before screening and at least 6 months after the last drug administration, taking effective contraceptive measures voluntarily and no sperm or egg donation plan; 4) Subjects can communicate well with researchers, fully understand the purpose, nature, methods and possible adverse reactions of the experiment, understand and abide by the requirements of this study, volunteer as subjects, and sign an informed consent form approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1) those who have participated in any clinical trials of drugs or used research drugs or who have not participated in clinical trials themselves within 3 months before screening; 2) Screening patients with chronic or active digestive tract diseases such as esophageal diseases, gastritis, peptic ulcer, enteritis, active gastrointestinal bleeding or digestive tract surgery in the first 3 years and those who the researchers think are still of clinical significance; 3) Patients with cardiovascular system (such as thromboembolism and hypertension), endocrine system (such as diabetes), genitourinary system, mental nervous system (such as dizziness, syncope and cerebral hemorrhage), hematology (such as anemia or hemophilia), immune system (including hereditary immunodeficiency in personal or family history), respiratory system, skeletal muscle, chronic skin diseases or serious diseases, which researchers think are still clinically significant (consultation) 4) Patients with any diseases that increase the risk of bleeding within 6 months before screening, such as intraocular hemorrhage, hemorrhoids, hematoma, hematochezia, hematemesis, hematuria, reproductive tract hemorrhage, angioretinopathy, bronchiectasis or pulmonary hemorrhage, or patients with any coagulation dysfunction or a history of hemorrhagic diseases; 5) Gingival bleeding and nosebleeds occurred within 14 days before screening, and the researchers believe that it is still clinically significant; 6) Have a history of allergy to drugs, food or other substances, or have a history of allergic diseases (such as anaphylactic shock and angioedema), and the researchers believe that it is still clinically meaningful; 7) those who can't tolerate venous puncture or have a history of fainting blood and needles; 8) Patients who have received surgery that will affect the absorption, distribution, metabolism and excretion of drugs according to the researcher's judgment within 6 months before screening; Or those who have undergone surgery or biopsy or have major trauma within 3 months before screening and the researchers judge that they are not suitable for entering the trial; Or those who plan to have surgery during the study period, or those who plan to have surgery within 4 weeks after the trial is released; 9) Those who have taken any medicine (including Chinese herbal medicine) orally within 14 days before screening; 10) Any CYP3A4 or P-gp inhibitor (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, erythromycin, clarithromycin, dronedarone, HIV protease inhibitor (ritonavir), verapamil, diltiazem, amiodarone, cyclosporine and tacrolimus) or CYP3A has been used within 30 days before screening. 11) any anticoagulant drugs have been used within 30 days before screening, such as ordinary heparin, low molecular weight heparin (enoxaparin and daparinux), heparin derivatives (fondaparinux sodium and desiluridine), thrombolytic drugs, vitamin K antagonists, rivaroxaban and apixaban, or antiplatelet aggregation drugs such as GP?b/?a receptor antagonists, ticlopidine and dipyridamole. 12) Those who have used any antiepileptic drugs, non-steroidal anti-inflammatory drugs (NSAID), serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine reuptake inhibitors (SNRIs) within 30 days before screening; 13) those who have been vaccinated within 2 weeks before screening, or who plan to be vaccinated during the trial; 14) Those who donated blood or lost a lot of blood (=400
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 ContactHu Yiting
Hebei General Hospital
Outcome results
None listed