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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000609-18 | EudraCT Number |
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Researchers are looking for a better way to treat venous thromboembolic disease, also known as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These clots or a piece of a clot can break free and move around the body in the blood vessels. These clots can block small blood vessels, causing other conditions like high blood pressure, heart attack, and stroke.
Before people with a medical condition can take an approved treatment in a new form, researchers do trials in healthy participants. This helps them understand how the new form acts in the body and to better understand its safety.
In this trial, the researchers will compare how much of the trial treatment gets into the blood when taken in 2 different forms in a small number of participants. The trial will include about 30 men who are aged 18 to 55.
In this trial, there will be 2 groups of participants. The participants will take rivaroxaban in the current tablet form and in a new liquid form 1 time. This was a "crossover" trial. In a crossover trial, all the participants will take both forms of the treatments, but in a different order.
During the trial, the participants will stay at their trial site 2 times for 5 days. But, the participants can be in the trial for up to about 6 weeks. During the trial, the doctors will take blood and urine samples and check the participants' heart health using an electrocardiogram (ECG) and measure the blood pressure. The participants will also answer questions about how they are feeling, if they have any medical problems, and about any medications they are taking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Single oral dose of a 20 mg tablet rivaroxaban | Experimental | 2-way crossover: The subjects will receive the following treatments in a randomized order:
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| Treatment B: Single oral dose of 20 mg rivaroxaban, granules | Experimental | 2-way crossover: The subjects will receive the following treatments in a randomized order:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg tablet rivaroxaban | Drug | Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC of rivaroxaban granules for oral suspension vs. rivaroxaban tablet | AUC = area under the concentration vs. time curve from zero to infinity after single (first) dose Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma. | From pre-dose up to 72 hours after drug administration |
| AUC(0-tlast) of rivaroxaban granules for oral suspension vs. rivaroxaban tablet | AUC(0-tlast) = AUC from time 0 to the last data point > lower limit of quantification (LLOQ) Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma. | From pre-dose up to 72 hours after drug administration |
| Cmax of rivaroxaban granules for oral suspension vs. rivaroxaban tablet | Cmax = maximum observed drug concentration in measured matrix after single dose administration Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma. | From pre-dose up to 72 hours after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Adverse events occurring in the period between the signing of the informed consent and the end of the follow-up phase. | Up to 7-14 days after the last administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| 20 mg rivaroxaban, granules for oral suspension | Drug | Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. |
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| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |