Anticoagulant treatment
Conditions
Interventions
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the content of the informed consent form, and voluntarily participate in the experiment; 2. The subjects are able to communicate well with the researchers and complete the experiment according to the protocol requirements; 3. The subjects (including male subjects) are willing to have no pregnancy plan from the screening date to 6 months after the end of the experiment and voluntarily take effective contraceptive measures; 4. Healthy male or female subjects aged 18 or above (including those aged 18); 5. Male subjects should weigh no less than 50 kilograms, while female subjects should weigh no less than 45 kilograms. Body mass index (BMI)=weight (kg)/height 2 (m2), with a body mass index ranging from 19.0 to 26.0kg/m2 (including critical values).
Exclusion criteria
Exclusion criteria: 1. Subjects with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, food, such as milk and pollen), or known allergic to rivaroxaban or any excipients; 2. Have any clinical history of serious diseases (including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychiatric system, facial features and other related diseases); 3. Subjects with clinically significant active bleeding, such as those with a history of any disease that may increase the risk of bleeding within 6 months, such as acute gastritis or gastric and duodenal ulcers, periodontal disease, bloody stools, hematuria, reproductive tract bleeding (including excessive menstruation), nasal bleeding, etc; 4. Lesions or conditions with a significant risk of major bleeding, such as malignant tumors with a high risk of bleeding, brain or spinal cord injuries, brain, spinal cord, or ophthalmic surgeries, intracranial bleeding, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major spinal or cerebral vascular malformations; 5. Liver disease patients with coagulation abnormalities and clinically related bleeding risks, including liver cirrhosis subjects reaching Child Pugh B and C levels; 6. Have a history of dysphagia or any gastrointestinal disease affecting absorption; 7. Those with clinical significance (subject to the judgment of the research doctor) who have abnormal physical examination, electrocardiogram, vital signs and laboratory examination (routine blood test, routine urine test, blood biochemistry, coagulation function, hepatitis B, hepatitis C, AIDS, syphilis) within 14 days before taking the study drug; 8. Those who have undergone major surgical procedures within 6 months prior to taking the study drug; 9. Those who have used drugs within the first 3 months of screening, or have a history of drug abuse within the first 12 months of screening, or those who have been screened positive for drug abuse (urine drug screening); 10. Smoking more than 5 cigarettes per day within the first 3 months of screening, or unable to stop consuming any tobacco products during the study period; 11. Regular drinkers within the first 6 months of screening, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of 5% alcohol beer, 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or those whose alcohol breath test results are greater than 0mg/100mL, or whose alcohol intake cannot be stopped during the study period; 12. Those who donate blood within the first 3 months of screening, including component blood or a large amount of blood loss (= 200mL), receive blood transfusions or use blood products; 13. Take any drug that changes the gastrointestinal environment (such as proton pump inhibitors, tetoprazole, omeprazole, lansoprazole, esomeprazole, etc.) within 30 days before screening; histamine receptor (H2) antagonists, ranitidine, cimetidine, famotidine, etc; Anti acid agents such as sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc; Gastric mucosa protective agent sucralfate, etc.) or drugs with liver enzyme activity (such as inducers barbiturates, carbamazepine, phenytoin sodium, dexamethasone, etc.; inhibitors SSRI antidepressants, ciprofloxacin, cimetidine, diltiazem, macrolides, metronidazole, ketoconazole,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;t1/2z;Tmax; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed