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Completed

NCT Number: NCT01853800

Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

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.

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Key information

Conditions

Biological Availability

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Wuppertal, North Rhine-Westphalia, 42096, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 15, 2013
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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