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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

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ClinicalTrials.gov Identifier: NCT04511611
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Clinical Pharmacology Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 24, 2019
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : May 13, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test A: 10 mg ODT with water, then 10 mg film-coated tablet
Participants received one single dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban film-coated tablet in the fasted state
 Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)

Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
10 mg as 1 x 10 mg film-coated tablet
Experimental: Test A: 10 mg film-coated tablet, then 10 mg ODT with water
Participants received one single dose of 10 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state
 Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)

Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
10 mg as 1 x 10 mg film-coated tablet
Experimental: Test B: 10 mg ODT without water, then 10 film-coated tablet
Participants received one single dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban film-coated tablet in the fasted state
 Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)

Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
10 mg as 1 x 10 mg film-coated tablet
Experimental: Test B: 10 mg film-coated tablet, then 10 mg ODT without water
Participants received one single dose of 10 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state
 Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)

Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
10 mg as 1 x 10 mg film-coated tablet


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events [ Time Frame: Up to 30 days after study medication ]

Eligibility Criteria
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Information from the National Library of Medicine

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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, 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
Contacts and Locations
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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): NCT04511611


Locations
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Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan, 130-0004
Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
Medical Co. LTA Nishikumamoto hospital
Kumamoto, Japan, 861-4157
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04511611    
Other Study ID Numbers: 20087
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants