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AzTrials

Clinical PharmacologyPhase 1NCT04511637

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

A Phase 1 study testing Rivaroxaban (BAY 59-7939, Xarelto) in ODT form and Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form in people with Clinical Pharmacology, run by Bayer at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Clinical Pharmacology
What is being tested?
Rivaroxaban (BAY 59-7939, Xarelto) in ODT form and Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesJapan
Study dates
21 Jan 2019to 12 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

3 sites in 1 country.

Japan3 sites

  • Fukuoka Mirai Hospital

    Fukuoka, 813-0017

  • Medical Co. LTA Nishikumamoto hospital

    Kumamoto, 861-4157

  • Sumida Hospital

    Sumida-ku, Tokyo, 130-0004

Other trials in Japan

About this study

Official 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

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (BAY 59-7939, Xarelto) in ODT formDrug

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

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

    15 mg as 1 x 15 mg film-coated tablet

Study groups in NCT04511637
Study groupRoleWhat they receive
Test C: 15 mg ODT with water, then 15 mg film-coated tabletExperimentalParticipants received one single dose of 15 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 15 mg rivaroxaban film-coated tablet in the fasted state
Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Test C: 15 mg film-coated tablet, then 15 mg ODT with waterExperimentalParticipants received one single dose of 15 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state
Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Test D: 15 mg ODT without water, then 15 film-coated tabletExperimentalParticipants received one single dose of 15 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 15 mg rivaroxaban film-coated tablet in the fasted state
Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Test D: 15 mg film-coated tablet, then 15 mg ODT without waterExperimentalParticipants received one single dose of 15 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state
Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax for plasma rivaroxaban concentration

    Maximum observed concentration

    Measured: Up to 48 hours after study medication

  2. 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

    Measured: Up to 48 hours after study medication

Secondary outcomes (1)

  1. Number of subjects with treatment-emergent adverse events

    Measured: Up to 30 days after study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2020
  2. Study start21 Jan 2019
  3. Primary completion7 Mar 2019
  4. Study completion12 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511637
Sponsor's protocol ID
20088
Status last verified
Aug 2020
First submitted
12 Aug 2020
Last updated
13 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rivaroxaban (BAY 59-7939, Xarelto) in ODT form and Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form in people with Clinical Pharmacology, run by Bayer at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax for plasma rivaroxaban concentration (time frame: Up to 48 hours after study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04511637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.

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