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Trial record 65 of 854 for:    tablet | Japan

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

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.

Condition or disease Intervention/treatment Phase
Embolism, Atrial Fibrillation and Venous Thrombosis Drug: Rivaroxaban (BAY 59-7939) Drug: Rivaroxaban (Xarelto, BAY 59-7939) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: BAY59-7939 granule Drug: Rivaroxaban (BAY 59-7939)
Rivaroxaban granule 10mg for one day

Active Comparator: BAY59-7939 tablet Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Rivaroxaban tablet 10mg for one day




Primary Outcome Measures :
  1. Cmax (maximum observed drug concentration in measured matrix after single dose administration) [ Time Frame: Multiple time point up to 3 day ]
  2. 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 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 day ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537405


Locations
Japan
Kumamoto, Japan, 861-4157
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02537405     History of Changes
Other Study ID Numbers: 17018
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants