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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04511637
Other study ID # 20088
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 21, 2019
Est. completion date April 12, 2019

Study information

Verified date August 2020
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 12, 2019
Est. primary completion date March 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban (BAY 59-7939, Xarelto) in ODT form
15 mg as 1 x 15 mg orally disintegrating tablet (ODT)
Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
15 mg as 1 x 15 mg film-coated tablet

Locations

Country Name City State
Japan Fukuoka Mirai Hospital Fukuoka
Japan Medical Co. LTA Nishikumamoto hospital Kumamoto
Japan Sumida Hospital Sumida-ku Tokyo

Sponsors (2)

Lead Sponsor Collaborator
Bayer Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax for plasma rivaroxaban concentration Maximum observed concentration Up to 48 hours after study medication
Primary 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 Up to 48 hours after study medication
Secondary Number of subjects with treatment-emergent adverse events Up to 30 days after study medication
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