check_circleStudy Completed

Healthy Volunteers

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years

Trial summary

Enrollment Goal
30
Trial Dates
July 2017 - October 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    From pre-dose up to 72 hours after drug administration.

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 7-14 days after the last administration

Trial design

Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 20 mg granules for oral suspension rivaroxaban versus 20 mg tablets rivaroxaban under fed condition in healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2