Clinical PharmacologyPhase 1NCT04511611
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
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.
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 10 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
- 24 Jan 2019to 13 May 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
About this study
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
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.
- Conditions
- Clinical Pharmacology
- 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
10 mg as 1 x 10 mg orally disintegrating tablet (ODT)
Rivaroxaban (BAY 59-7939, Xarelto) in film-coated formDrug
10 mg as 1 x 10 mg film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Test A: 10 mg ODT with water, then 10 mg film-coated tablet | Experimental | 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 Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form |
| Test A: 10 mg film-coated tablet, then 10 mg ODT with water | Experimental | 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 Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form |
| Test B: 10 mg ODT without water, then 10 film-coated tablet | Experimental | 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 Receives: Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form |
| Test B: 10 mg film-coated tablet, then 10 mg ODT without water | Experimental | 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 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.
Cmax for plasma rivaroxaban concentration
Maximum observed concentration
Measured: 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
Measured: Up to 48 hours after study medication
Secondary outcomes (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.
- First posted13 Aug 2020
- Study start24 Jan 2019
- Primary completion27 Mar 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511611
- Sponsor's protocol ID
- 20087
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511611
- Acronym / sponsor ID
- 20087
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test A: 10 mg ODT with water, then 10 mg film-coated tablet | Experimental | Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated formParticipants 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 |
| Test A: 10 mg film-coated tablet, then 10 mg ODT with water | Experimental | Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated formParticipants 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 |
| Test B: 10 mg ODT without water, then 10 film-coated tablet | Experimental | Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated formParticipants 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 |
| Test B: 10 mg film-coated tablet, then 10 mg ODT without water | Experimental | Drug: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Drug: Rivaroxaban (BAY 59-7939, Xarelto) in film-coated formParticipants 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m²
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (BAY 59-7939, Xarelto) in ODT form10 mg as 1 x 10 mg orally disintegrating tablet (ODT) | Drug | Test A: 10 mg ODT with water, then 10 mg film-coated tablet, Test A: 10 mg film-coated tablet, then 10 mg ODT with water, Test B: 10 mg ODT without water, then 10 film-coated tablet, Test B: 10 mg film-coated tablet, then 10 mg ODT without water |
| Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form10 mg as 1 x 10 mg film-coated tablet | Drug | Test A: 10 mg ODT with water, then 10 mg film-coated tablet, Test A: 10 mg film-coated tablet, then 10 mg ODT with water, Test B: 10 mg ODT without water, then 10 film-coated tablet, Test B: 10 mg film-coated tablet, then 10 mg ODT without water |
Primary outcome
Cmax for plasma rivaroxaban concentration
Time frame: Up to 48 hours after study medication
Maximum observed concentration
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
1 secondary outcome
Number of subjects with treatment-emergent adverse events
Time frame: Up to 30 days after study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 6 Nov 2026.