Healthy Subjects
Conditions
Keywords
rivaroxaban, pharmacokinetics, bioequivalence
Brief summary
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.
Detailed description
Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.
Interventions
DRUGRivaroxaban 20 MG Oral Tablet [Xarelto]
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study was designed as a four-period complete and replicate crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female aged 18 and above. * The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. * The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test. * The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects * Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Exclusion criteria
* Being allergy to the study medications, smoking, alcohol abuse. * Participation in another clinical trial within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 94 days | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC)0-t | 94 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t |
| Area under the plasma concentration versus time curve (AUC)0-∞ | 94 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal pulse | 94 days | Monitor the pulse |
| Incidence of Treatment-Emergent Adverse Events | 94 days | Collection of adverse events |
| Incidence of abnormal electrocardiogram waveform | 94 days | Electrocardiogram inspection |
| Incidence of abnormal blood pressure | 94 days | Monitor the blood pressure |
| Incidence of abnormal temperature | 94 days | Monitor the temperature |
Countries
China
Outcome results
None listed