check_circleStudy Completed
Healthy Volunteers
Bayer Identifier:
19366
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A trial to learn how much rivaroxaban gets into the blood when taken in different forms and how safe they are in healthy men
Trial purpose
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.
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.
Key Participants Requirements
Sex
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
30Trial Dates
July 2017 - October 2017Phase
Phase 1Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Primary Outcome
- AUC of rivaroxaban granules for oral suspension vs. rivaroxaban tabletAUC = area under the concentration vs. time curve from zero to infinity after single (first) dose Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.date_rangeTime Frame:From pre-dose up to 72 hours after drug administration
- AUC(0-tlast) of rivaroxaban granules for oral suspension vs. rivaroxaban tabletAUC(0-tlast) = AUC from time 0 to the last data point > lower limit of quantification (LLOQ) Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.date_rangeTime Frame:From pre-dose up to 72 hours after drug administration
- Cmax of rivaroxaban granules for oral suspension vs. rivaroxaban tabletCmax = maximum observed drug concentration in measured matrix after single dose administration Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.date_rangeTime Frame:From pre-dose up to 72 hours after drug administration.
Secondary Outcome
- Number of treatment-emergent adverse eventsAdverse events occurring in the period between the signing of the informed consent and the end of the follow-up phase.date_rangeTime Frame:Up to 7-14 days after the last administration
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2