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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000648-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Researchers were looking for another way to treat people with a blood clot in their veins. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it behaves.
In this trial, the researchers learned how a new liquid form of rivaroxaban behaved compared to the tablet form in a small number of healthy participants. They also wanted to find out how safe it was. The trial included about 30 white men who were between the ages of 18 and 55. The participants also had a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m^2). BMI is a measurement that uses a person's height and weight to learn how much body fat they have.
All the participants in this trial took 10 milliliter of the new form of rivaroxaban (containing 1 milligram [mg] of rivaroxaban per milliliter). Later they also took 10 mg of the current tablet form of rivaroxaban. They took each form 1 time by mouth.
This trial was a "crossover" trial. In a crossover trial, all the participants take all of the treatments, but in a different order. In between the 2 treatments, there was a "washout period" of at least 7 days. This was done so that the first treatment could leave each participant's body before they took their next treatment.
While taking each treatment, the participants stayed at the trial site for 5 days. During this time, they did not eat food for at least 10 hours before and at least 4 hours after taking each treatment. After taking the last treatment, the participants had a final visit about 7 to 14 days later.
During the trial, the doctors took blood and urine samples. They also did physical examinations and checked the participants' heart health using an electrocardiogram (ECG). They asked the participants questions about how they were feeling and if they had any medical problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A-B | Experimental | Subjects received a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments. |
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| Treatment B-A | Experimental | Subjects received a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Granules for oral suspension, 10 mg, oral, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from zero to infinity (AUC) of rivaroxaban in plasma after single dose | Pre-dose up to 72 hours post-dose | |
| AUC from time zero to the last data point greater than (>) lower limit of quantification (LLOQ) (AUC[0-tlast]) of rivaroxaban in plasma after single dose | Area under the concentration versus time curve from zero to infinity (AUC) | Pre-dose up to 72 hours post-dose |
| Maximum observed drug concentration (Cmax) of rivaroxaban in plasma after single dose | Pre-dose up to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | From start of study drug administration up to 30 days after last study drug 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 |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Tablet, 10 mg, oral, single dose |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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