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Completed

NCT Number: NCT04511637

Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects

Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water.

Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida Hospital, Sumida-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m²

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 known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Subject with known coagulation disorders (e.g. von Willebrand disease, hemophilia)
  • Subject with febrile illness within 1 week before the first study drug administration
  • Subject with suspicion of drug or alcohol abuse
  • Subject with intake of foods or beverages containing grapefruit, pomelo, Seville orange, and tangelo within 1 week before the first study drug administration
  • Subject with therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment
  • Subject with clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the corrected QT (QTc) interval over 450 msec
  • Subject with systolic blood pressure below 90 or above 130 mmHg
  • Subject with diastolic blood pressure below 45 or above 85 mmHg
  • Subject with clinically relevant deviations of the screened laboratory parameters from reference ranges

Treatment and study plan

Rivaroxaban (BAY 59-7939, Xarelto) in ODT form

Drug

15 mg as 1 x 15 mg orally disintegrating tablet (ODT)

Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form

Drug

15 mg as 1 x 15 mg film-coated tablet

Primary outcomes

  1. Cmax for plasma rivaroxaban concentration

    Time frame: Up to 48 hours after study medication

    Maximum observed concentration

  2. AUC(0-tlast) for plasma rivaroxaban concentration

    Time frame: Up to 48 hours after study medication

    Area under the concentration versus time curve from time 0 to the last data point > lower limit of quantitation

Secondary outcomes

  1. Number of subjects with treatment-emergent adverse events

    Time frame: Up to 30 days after study medication

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between a Rivaroxaban 15 mg Orally Disintegrating Tablet Administered With Water or Without Water and a Rivaroxaban 15 mg Film-coated Tablet in Japanese Healthy Male Adult Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

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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