Thromboembolism disease
Conditions
Interventions
Fasting -A group:Administration under fasting condition (TRTR)
Fed -C group:Administration under fed condition (TRTR)
Fasting -B group:Administration under fasting condition (RTRT)
Fed -D group:Administration under fed condition (RTRT)
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Chinese healthy volunteers between the ages of 18 and 60 (including boundary values) men and women; 2) The weight of male volunteers is >=50.0 kg, the weight of female volunteers is >=45.0 kg, and the body mass index (BMI) is 19 to 26 kg / m2 (including the boundary value). Body mass index (BMI) = body weight (kg) / height 2 (m2); 3) Sign the informed consent before the test, and fully understand the test content, process, and possible adverse reactions; 4) Volunteers can communicate well with researchers and understand and abide by the requirements of this research.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic or allergic to rivaroxaban tablets or any ingredients (such as lactose) in their accessories; 2) Whether you have any previous disease that increases the risk of bleeding or coagulation dysfunction, such as hemophilia, periodontal disease, hemorrhoids, acute gastritis or peptic ulcer, hematoma, rectal bleeding, hematemesis, hematuria, genital tract bleeding ( Including hypermenorrhea), epistaxis, intracranial hemorrhage, clinically significant thrombocytopenia or anemia; 3) Those who have a history of previous or existing hemorrhage risk; 4) Known or suspected esophageal varicose veins, arteriovenous malformations, vascular aneurysms, or major spine or cerebral vascular malformations 5) Those with previous or existing history of thrombocytopenic purpura; 6) Those who have had a history of dysphagia, peptic ulcer or any gastrointestinal system diseases and affected the absorption of drugs, and now feel gastrointestinal discomfort; 7) There is a history of cardiovascular system, endocrine system, nervous system, blood system, immune system (including hereditary immunodeficiency in personal or family history), psychosis, metabolic abnormalities, malignant tumors, lymphoproliferative diseases, etc. Those with clinical significance; 8) Those with postural hypotension, history of halo needles or haloblood, or intolerance to venipuncture blood collection. Other exclusions: participation in clinical trials, medical history, surgical history, vaccine history, blood donation / menstrual history of women, tea and coffee or caffeinated beverage use history, smoking status, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed