Prevention of thrombosis
Conditions
Interventions
Fed Conditions A:Phase I:Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Phase II:Rivaroxaban tablets manufactured by Bayer Pharma AG
Phase III:Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Phase IV:Rivaroxaban tablets manufactured by Bayer Pharma AG
Fed Conditions B:Phase I: Rivaroxaban tablets manufactured by Bayer Pharma AG
Phase II: Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Phase III: Rivaroxaban tablets manufactured by Bayer Pharma AG
Phase IV: Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Fasting Conditions A:Phase I: Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Phase II: Rivaroxaban tablets manufactured by Bayer Pharma AG
Phase III: Rivaroxaban tablets produced by Shaanxi Buchang Gaoxin Pharmaceutical Co., LTD
Phase IV: Rivaroxaban tablets manufactured by Bayer Pharma AG
Fasting Conditions B:Phase I: Rivaroxaban tablets manufactured by Bayer Pharma AG
Sponsors
Guangzhou Panyu Central Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 47 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects, 18 to 65 years old (including boundary values); 2. Female weight >= 45kg, male weight >= 50kg, BMI 18.0-26.0kg /m2 (including boundary value, calculation formula = weight/height2); 3. Normal coagulation function; 4. Endogenous creatinine clearance rate >50 mL/min; 5. Subjects should be willing to take effective contraceptive measures from 2 weeks before screening to 3 months after the last administration to avoid pregnancy of subjects or their spouses; 6. Subject's informed consent and voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with chronic medical history of heart, liver, kidney, endocrine, digestive tract, blood system, nervous system and respiratory system or existing diseases of these systems (especially those with cardiovascular diseases (including those at risk of cardiovascular diseases), gastrointestinal bleeding, hemorrhagic diseases, hemorrhoids, urticaria, epilepsy and asthma); A previous history of mental illness; 2. Women with a past history of dysfunctional uterine bleeding, including excessive menstrual bleeding, irregular uterine bleeding, or long menstrual cycle (period length >7 days); 3. Women who were menstruating at the time of the first cycle; 4. Pregnant and lactating women or female subjects who have had unprotected sex in the last two weeks; Positive pregnancy test; 5. Abnormalities in physical examination, vital signs measurement, blood routine examination, urine routine examination, blood biochemistry, coagulation function and 12-lead electrocardiogram before the test are clinically significant as determined by clinical research doctors; 6. HIV antibody, HEPATITIS B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody test results of one or more positive; 7. Allergic constitution (allergic to two or more allergens), allergic to drugs and food; 8. Is the first study drug within 30 days before using any interaction with the cut shaaban drugs (such as CYP3A4 or P - gp inhibitors ketone health zun, itraconazole, clarithromycin, erythromycin, fluconazole, aza that wei, indiana that wei, naphthalene sanzuotong, the way of the wei, the wei, ShaKui that wei, tillie toxin, voriconazole, etc; CYP3A4 inducer dexamethasone, phenytoin, carbamazepine, rifampicin, rifambutin, rifapentine, phenobarbital, St. John's Herb, etc.), or those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products (except birth control pills) within 14 days before first administration; 9. Those who have special dietary requirements and cannot accept the provided diet or corresponding regulations; Have taken a special diet (including dragon fruit, mango, grapefruit, chocolate, caffeinated coffee, or any caffeinated food or beverage, etc.) or excessive tea drinks (more than 8 cups per day, 1 cup =250mL) within 1 week before administration; 10. Those who have a habit of smoking (smoking more than 5 cigarettes per day in the 3 months before the trial) or cannot give up smoking during the whole study period; 11. Have an alcoholic habit (i.e., more than 28 standard units per week for men and more than 21 standard units per week for women) (1 standard unit containing 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine); Or regular alcohol consumption (more than 14 standard units per week) in the 6 months prior to the trial; Or have taken any alcohol product within 24 hours before taking the drug and have been tested positive for alcohol breath test; 12. Those who have a history of drug abuse or drug abuse or whose urine drug screening results are positive; 13. Those who had donated blood or had a large amount of bleeding (> 400mL) within 3 months prior to the first drug administration, or planned to donate blood or blood components during the study period; 14. Persons suffering from hereditary lactose or galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; 15. Participants in, or currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rivaroxaban in plasma; | — |
Countries
China
Contacts
Public ContactYang Hui
Guangzhou Panyu Central Hospital
Outcome results
None listed