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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001720-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders. Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight. The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban (Treatment A) suspension (BN03501), fasted | Experimental | Subjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment A, Batch number BN03501) under fasting conditions in any intervention period. |
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| Rivaroxaban (Treatment B) suspension (BN03501), fed | Experimental | Subjects received single oral dose of Rivaroxaban suspension 20 mg (Treatment B, Batch number BN03501) under fed conditions in any intervention period. |
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| Rivaroxaban (Treatment C) suspension (BR05701), fasted | Experimental | Subjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment C, Batch number BR05701) under fasting conditions in any intervention period. |
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| Rivaroxaban (Treatment D) IR tablet, fasted | Experimental | Subjects received single oral dose of Rivaroxaban IR tablet 10 mg (Treatment D) under fasting conditions in any intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC) | 0-72 hours | |
| Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) | 0-72 hours | |
| Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax) | 0-72 hours | |
| Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D) | 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) | 0-72 hours | |
| Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)] | 0-72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuppertal | North Rhine-Westphalia | 42096 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) | 0-72 hours |
| Mean Residence Time (MRT) | 0-72 hours |
| Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h) | 0-72 hours |
| Time to Reach Maximum Observed Drug Concentration (tmax) | 0-72 hours |
| Terminal Half Life (t1/2) | 0-72 hours |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |