check_circleStudy Completed

embolism, atrial fibrillation and venous thrombosis

Bayer Identifier:

17018

ClinicalTrials.gov Identifier:

NCT02537405

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bioequivalence study of Rivaroxaban in Japanese healthy adult male subjects

Trial purpose

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.

Key Participants Requirements

Sex

Male

Age

20 - 40 Years
  • - Japanese healthy male subjects
    - 20 to 40 years of age
    - 17.6 to 26.4 kg / m² of body mass index (BMI)
  • - Subject with 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
    - Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
    - Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
    - Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
    - Subject with known sensitivity to common causes of bleeding (eg nasal)

Trial summary

Enrollment Goal
40
Trial Dates
February 2014 - April 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
N/A
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Medical Co. LTA Nishikumamoto hospitalKumamoto, 861-4157, Japan

Primary Outcome

  • Cmax (maximum observed drug concentration in measured matrix after single dose administration)
    date_rangeTime Frame:
    Multiple time point up to 3 day
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    Safety Issue:
    No
  • AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
    date_rangeTime Frame:
    Multiple time point up to 3 day
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 30 day
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Randomized, non-blinded, two-way crossover study to establish the bioequivalence between a rivaroxaban tablet 10 mg and a rivaroxaban granule 10 mg in Japanese healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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