check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

20087

ClinicalTrials.gov Identifier:

NCT04511611

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to compare the effect of the formulations (orally disintegrating tablet and film-coated tablet) on bioequivalence of drug Rivaroxaban (Xarelto) at dose of 10 mg in Japanese healthy male adult subjects

Trial purpose

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 10 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 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 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.

Key Participants Requirements

Sex

Male

Age

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

Trial summary

Enrollment Goal
80
Trial Dates
January 2019 - May 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Rivaroxaban (BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Fukuoka Mirai HospitalFukuoka, 813-0017, Japan
Completed
Medical Co. LTA Nishikumamoto hospitalKumamoto, 861-4157, Japan
Completed
Sumida HospitalSumida-ku, 130-0004, Japan

Primary Outcome

  • Cmax for plasma rivaroxaban concentration
    Maximum observed concentration
    date_rangeTime Frame:
    Up to 48 hours after study medication
  • AUC(0-tlast) for plasma rivaroxaban concentration
    Area under the concentration versus time curve from time 0 to the last data point > lower limit of quantitation
    date_rangeTime Frame:
    Up to 48 hours after study medication

Secondary Outcome

  • Number of subjects with treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 30 days after study medication

Trial design

Randomized, non-blinded, two-way crossover study to assess bioequivalence between a rivaroxaban 10 mg orally disintegrating tablet administered with water or without water and a rivaroxaban 10 mg film-coated tablet in Japanese healthy male adult subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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