check_circleStudy Completed
Biological Availability
Bayer Identifier:
16886
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
14Trial Dates
May 2013 - August 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
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 hoursenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
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 hoursenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)]date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Mean Residence Time (MRT)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Drug Concentration (tmax)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
- Terminal Half Life (t1/2)date_rangeTime Frame:0-72 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
4Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis resultsClick here to find information about studies related to Bayer Healthcare products conducted in Europe.