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Completed

NCT Number: NCT02537457

Bioequivalence Study of Rivaroxaban

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.

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Key information

Conditions

Embolism, Atrial Fibrillation and Venous Thrombosis Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kumamoto, 861-4157, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivaroxaban (BAY 59-7939)

Drug

Rivaroxaban granule15mg for one day

Rivaroxaban (Xarelto, BAY 59-7939)

Drug

Rivaroxaban tablet15mg for one day

Primary outcomes

  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 outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 30 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2015
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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