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Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

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ClinicalTrials.gov Identifier: NCT02537405
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Cmax (maximum observed drug concentration in measured matrix after single dose administration) [ Time Frame: Multiple time point up to 3 day ]
  • AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation)) [ Time Frame: Multiple time point up to 3 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Embolism, Atrial Fibrillation and Venous Thrombosis
Intervention  ICMJE
  • Drug: Rivaroxaban (BAY 59-7939)
    Rivaroxaban granule 10mg for one day
  • Drug: Rivaroxaban (Xarelto, BAY 59-7939)
    Rivaroxaban tablet 10mg for one day
Study Arms  ICMJE
  • Experimental: BAY59-7939 granule
    Intervention: Drug: Rivaroxaban (BAY 59-7939)
  • Active Comparator: BAY59-7939 tablet
    Intervention: Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese healthy male subjects
  • 20 to 40 years of age
  • 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537405
Other Study ID Numbers  ICMJE 17018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP