A hip or knee replacement,Prevent venous thrombosis
Conditions
Interventions
Test preparation and fasting group:fasting delivery of test preparation Rivaroxaban Tablets (dose once,10mg)
Test preparation and fed group:fed delivery of test preparation Rivaroxaban Tablets (dose once,10mg)
Reference preparation and fasting group:fasting delivery of reference preparation Rivaroxaban Tablets (dose once,10mg)
Reference preparation and fed group:fed delivery of reference preparation Rivaroxaban Tablets (dose once,10mg)
Sponsors
The First Hosptial of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign informed consent forms,fully understanding the content and the process of the experiment as well as the adverse reactions that may arise; 2) To be able to complete the experiment according to the programme; 3) Subjects(including male subjects) are willing to have no planned parenthood and take effective contraceptives within 6 months in the future; 4) Healthy subjects over 18 years old(including 18), all genders; 5) The weight of subjects is not less than 50kg, BMI between 19~26(including critical value), BMI=weight(kg)/height^2(m^2); 6) Health condition: No madical history about heart, liver, kidney, dogestive tract, nervous system,ansanity or metabolic disorder etc; 7) Regular or no clinical significance by physical examinations,laboratory inspections, electrocardiography and X-Ray check; 8) Crcl>50mL/min.Crcl calculation,Cockcroft-Gault form:Crcl=[(140-age)*weight(kg)]/[0.814*Scr(umol/L)]. When calculating the endophytic Crcl, the units should be noticed.Women multiplied by 0.85[6,7].
Exclusion criteria
Exclusion criteria: 1) Daily smoking over 5 pieces; 2) Have a history of allergies to Rivaroxaban Tablets or its excipients; 3) Have a history of drug and/or alcohol abuse(14 units of alcohol per week,1 unit=beer 285mL,or spirits 25mL,or wine 100mL);or the results of common drugs check and breathalyzer are positive; 4) Blood donation or extensive blood loss(<450mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs,non-prescription drugs,any vitamin products or herbs within 14 days prior to taking the study drug; 7) Take grapefruits or any product that contains grapefruit juice within 7 days before taking the study drug; 8) Intake any food or drink that contains caffeine within 48 hours before taking the study drug such as coffee,tea, chocolate,etc; 9) Take any products that contain alcohol within 24 hours before taking the study drug; 10) Take the study drugs or participate in drug clinical test within 3 months before taking the study drug; 11) suffer from any disease that increases hemorrhagic risk such as Periodontal disease, Hemorrhoids, Acute gastritis or The digestive tract ulcer, The Hematoma, Rectal bleeding, Hematemesis, Hematuria, Vaginal bleeding(including menorrhagia),Nose bleeding etc. 12) Have difficulty in swallowing or any history of gastrointestinal disease that affects the absorption of drugs; 13) Have any disease about coagulant dysfunction(such as hemophilia) or history of hemorrhagic disease; 14) Women who are pregnant,breastfeeding,scheduled to pregnancyor use drug contraception; 15) The screening of Hepatitis(including HBV and HCV),AIDS and Syphilis is positive; 16) Acute disease occurs in screening before the study or before taking drugs; 17) Investigators judged the possibility of joining the group was lower or it was short of obedience(such as weakness); 18) can't tolerate venous puncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Countries
China
Contacts
Public ContactFan Hongwei
The First Hospital of Nanjing
Outcome results
None listed