antithrombotic
Conditions
Interventions
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) subjects understand and follow the test procedures, participate voluntarily, and sign informed consent; 2) health volunteers over 18 years old (including 18 years old) are not limited to men and women; 3) women should weigh no less than 45.0 kg, men should weigh no less than 50.0 kg, and their body mass index (BMI) is between 19.0 and 28.0 kg/m2 (BMI = weight/height 2); 4) screening when vital signs: blood pressure, pulse, temperature, breathing (seat), physical examination, laboratory examination, electrocardiogram (ecg) no clinical significance test results such as normal or abnormal, the doctor said its good health; 5) the subjects (including their spouses) had no family planning during the study period and 6 months after the end of the study and voluntary effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) suffering from respiratory system, digestive system, cardiovascular system, blood and lymphatic system, spirit and the nervous system, reproductive and urinary system, liver, kidney and endocrine system metabolic abnormalities such as any clinical history of serious illness or any other disease which can interfere with the test results or physiological condition; 2) patients with diseases that increase the risk of bleeding in the last 6 months, such as acute gastritis or peptic ulcer, hematoma, rectal bleeding, hematemesis, hematuria, etc.; 3) patients with any coagulation disorder (such as hemophilia) or with a history of bleeding disorders; 4) a history of dysphagia or any gastrointestinal illness affecting drug absorption; 5) any examination results of hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody and HIV antibody were positive; 6) quantitative detection of >1.0*102 copies/ml of hepatitis b virus DNA; 7) took the study drugs within 3 months before taking the study drugs, or participated in the clinical trials of drugs; 8) use of other drugs within 4 weeks prior to taking the study drug, including any drugs that alter the activity of hepatic enzyme (such as CYP3A4, etc.); 9) people with a history of allergy to rivaroxaban tablets or any of its ingredients (such as lactose); 10) people with a history of severe allergy (allergic to two or more foods or medicines); 11) people with known hereditary galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption; 12) patients who cannot tolerate venipuncture for blood collection; 13) those who have taken any alcoholic product within 48 hours prior to taking the study drug; 14) those who smoked more than 5 cigarettes a day for nearly 3 months, or who refused to quit during the study period; 15) people with a history of alcoholism. Binge drinking is defined as those who regularly drink more than 14 units per week (1 unit = 150 mL wine or 360 mL beer or 45 mL spirits) or who have positive breathalyzer test; 16) those with a history of drug abuse or positive drug urine test; 17) blood donation or massive blood loss (> 400 mL) within 3 months prior to taking the study drug; 18) those who have eaten grapefruit or products containing grapefruit juice within 7 days prior to taking the study drug; 19) anyone who has consumed any caffeinated food or beverage, such as coffee, strong tea, chocolate, within 48 hours of taking the study drug; 20) women who are pregnant, lactating, planning to become pregnant or using medicated contraceptives; 21) patients with acute illness occurring in the pre-screening stage or before the study; 22) the researcher considers that it is inappropriate to participate in any other situation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;Blood coagulation function; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed