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NCT01853800 Clinical Trial

Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

Biological Availability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01853800
Other study ID # 16886
Secondary ID 2013-001720-19
Status Completed
Phase Phase 1
First received May 13, 2013
Last updated January 20, 2017
Start date May 2013
Est. completion date August 2013

Study information
Verified date January 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bayer Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Concentration Versus Time Curve From Zero to Infinity After a Single Dose (AUC) 0-72 hours
Primary Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) 0-72 hours
Primary Maximum Observed Drug Concentration in Measured Matrix After a Single Dose (Cmax) 0-72 hours
Primary Maximum Observed Drug Concentration in Measured Matrix Divided by Dose (Cmax/D) 0-72 hours
Secondary Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) 0-72 hours
Secondary Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0tlast)] 0-72 hours
Secondary Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) 0-72 hours
Secondary Mean Residence Time (MRT) 0-72 hours
Secondary Maximum Observed Drug Concentration Divided by Drug Concentration at 24 hours (Cmax/C24h) 0-72 hours
Secondary Time to Reach Maximum Observed Drug Concentration (tmax) 0-72 hours
Secondary Terminal Half Life (t1/2) 0-72 hours
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