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Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

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ClinicalTrials.gov Identifier: NCT01853800
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Biological Availability Drug: Rivaroxaban (Xarelto, BAY59-7939) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban (Treatment A) suspension (BN03501), fasted
Subjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment A, Batch number BN03501) under fasting conditions in any intervention period.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Experimental: Rivaroxaban (Treatment B) suspension (BN03501), fed
Subjects received single oral dose of Rivaroxaban suspension 20 mg (Treatment B, Batch number BN03501) under fed conditions in any intervention period.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Experimental: Rivaroxaban (Treatment C) suspension (BR05701), fasted
Subjects received single oral dose of Rivaroxaban suspension 10 mg (Treatment C, Batch number BR05701) under fasting conditions in any intervention period.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Experimental: Rivaroxaban (Treatment D) IR tablet, fasted
Subjects received single oral dose of Rivaroxaban IR tablet 10 mg (Treatment D) under fasting conditions in any intervention period.
Drug: Rivaroxaban (Xarelto, BAY59-7939)



Primary Outcome Measures :
  1. Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC) [ Time Frame: 0-72 hours ]
  2. Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) [ Time Frame: 0-72 hours ]
  3. Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax) [ Time Frame: 0-72 hours ]
  4. Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D) [ Time Frame: 0-72 hours ]

Secondary Outcome Measures :
  1. Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) [ Time Frame: 0-72 hours ]
  2. Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)] [ Time Frame: 0-72 hours ]
  3. Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) [ Time Frame: 0-72 hours ]
  4. Mean Residence Time (MRT) [ Time Frame: 0-72 hours ]
  5. Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h) [ Time Frame: 0-72 hours ]
  6. Time to Reach Maximum Observed Drug Concentration (tmax) [ Time Frame: 0-72 hours ]
  7. Terminal Half Life (t1/2) [ Time Frame: 0-72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects
  • Age: 18 to 55 years (inclusive) at the first screening examination

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853800


Locations
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Germany
Wuppertal, Nordrhein-Westfalen, Germany, 42096
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01853800    
Other Study ID Numbers: 16886
2013-001720-19 ( EudraCT Number )
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Bayer:
Relative bioavailability
Rivaroxaban
Additional relevant MeSH terms:
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Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants