check_circleStudy Completed

Biological Availability

Bayer Identifier:

16886

ClinicalTrials.gov Identifier:

NCT01853800

EudraCT Number:

2013-001720-19

EU CT Number:

Not Available
Relative bioavailability of oral suspension of rivaroxaban compared to standard tablet

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - Healthy male subjects
    - Age: 18 to 55 years (inclusive) at the first screening examination
  • - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
    - Known coagulation disorders (eg von Willebrand's disease, hemophilia)
    - Known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
    - Known sensitivity to common causes of bleeding (eg nasal)
    - Regular use of medicines
    - Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
    - Clinically relevant findings in the physical examination
    - Clinically relevant deviations of the screened laboratory parameters from reference ranges
    - Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

Trial summary

Enrollment Goal
14
Trial Dates
May 2013 - August 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42096, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)]
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Mean Residence Time (MRT)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Observed Drug Concentration (tmax)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Half Life (t1/2)
    date_rangeTime Frame:
    0-72 hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

Single-dose, open-label, randomized, 4-way crossover study to compare 10 mg of an oral suspension of rivaroxaban under fasting (2 different batches) and 20 mg of an oral suspension of rivaroxaban under fed conditions to 10 mg of an immediate release tablet under fasting conditions in healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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