healthy volunteers (Prevention and teatment of thromboembolic disorders) MedDRA version: 14.1 Level: LLT Classification code 10043640 Term: Thrombosis venous System Organ Class: 100000004866
Conditions
Interventions
Product Code: BAY59-7939
Pharmaceutical Form: Oral suspension
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: The secondary objective of the study is to assess the safety and tolerability of rivaroxaban ;Primary end point(s): none;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Germany
Contacts
Public ContactClinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed