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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban 20 MG Oral Tablet [Xarelto] | Active Comparator | rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg |
|
| Rivaroxaban 20 MG Oral Tablet | Experimental | rivaroxaban oral tablet at a single oral dose of 20 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 20 MG Oral Tablet [Xarelto] | Drug | The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto]. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 94 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 94 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 94 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 94 days |
| Incidence of abnormal blood pressure | Monitor the blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yu Cao | the study director of phase I clinical research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Center | Qingdao | Shandong | 266003 | China |
All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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The study was designed as a four-period complete and replicate crossover
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| Rivaroxaban 20 MG Oral Tablet | Drug | The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet. |
|
| 94 days |
| Incidence of abnormal temperature | Monitor the temperature | 94 days |
| Incidence of abnormal pulse | Monitor the pulse | 94 days |
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 94 days |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |