Relative bioavailability of oral suspension of rivaroxaban compared to standard tablet

Conditions: healthy volunteers (Prevention and teatment of thromboembolic disorders)
MedDRA version: 14.1Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-001720-19-DE

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to characterize the pharmacokinetics of 10 and 20 mg of rivaroxaban administered as an oral suspension in comparison to a 10 mg immediate release tablet. The potential for a food effect will be investigated for the 20 mg oral suspension <br>;Secondary Objective: The secondary objective of the study is to assess the safety and tolerability of rivaroxaban <br>;Primary end point(s): none;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures