Embolism, Atrial Fibrillation and Venous ThrombosisPhase 1NCT02537457
Bioequivalence Study of Rivaroxaban
A Phase 1 study testing Rivaroxaban (BAY 59-7939) and Rivaroxaban (Xarelto, BAY 59-7939) in people with Embolism, Atrial Fibrillation and Venous Thrombosis, run by Bayer at 1 site in Japan.
Trial summary
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects. 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
- Embolism, Atrial Fibrillation and Venous Thrombosis
- What is being tested?
- Rivaroxaban (BAY 59-7939) and Rivaroxaban (Xarelto, BAY 59-7939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Apr 2014
- 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
- 20 to 40 years of age
- 17.6 to 26.4 kg / m² of body mass index (BMI)
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 a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
- Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
- Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Subject with known sensitivity to common causes of bleeding (eg nasal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.
- Being tested
- Rivaroxaban (BAY 59-7939), Rivaroxaban (Xarelto, BAY 59-7939)
- Medical subject headings
- Embolism, Atrial Fibrillation, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (BAY 59-7939)Drug
Rivaroxaban granule15mg for one day
Rivaroxaban (Xarelto, BAY 59-7939)Drug
Rivaroxaban tablet15mg for one day
| Study group | Role | What they receive |
|---|---|---|
| BAY59-7939 Rivaroxaban granule | Experimental | Not described Receives: Drug: Rivaroxaban (BAY 59-7939) |
| BAY59-7939 Rivaroxaban tablet | Active comparator | Not described Receives: Drug: Rivaroxaban (Xarelto, BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Measured: Multiple time point up to 3 day
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
Measured: Multiple time point up to 3 day
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolism, Atrial Fibrillation and Venous ThrombosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537457
- Sponsor's protocol ID
- 17017
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02537457
- Acronym / sponsor ID
- 17017
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Sep 2015 (estimated)
- 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.
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY59-7939 Rivaroxaban granule | Experimental | Drug: Rivaroxaban (BAY 59-7939) |
| BAY59-7939 Rivaroxaban tablet | Active comparator | Drug: Rivaroxaban (Xarelto, BAY 59-7939) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese healthy male subjects
- 20 to 40 years of age
- 17.6 to 26.4 kg / m² of body mass index (BMI)
Key exclusion criteria (5 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 a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
- Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
- Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Subject with known sensitivity to common causes of bleeding (eg nasal)
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)Rivaroxaban granule15mg for one day | Drug | BAY59-7939 Rivaroxaban granule |
| Rivaroxaban (Xarelto, BAY 59-7939)Rivaroxaban tablet15mg for one day | Drug | BAY59-7939 Rivaroxaban tablet |
Primary outcome
Cmax (maximum observed drug concentration in measured matrix after single dose administration)
Time frame: Multiple time point up to 3 day
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
Time frame: Multiple time point up to 3 day
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 30 day
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 1 Sep 2015.
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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.
Bayer Study Director study director
Bayer
1 site 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) and Rivaroxaban (Xarelto, BAY 59-7939) in people with Embolism, Atrial Fibrillation and Venous Thrombosis, run by Bayer at 1 site 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 3 inclusion and 5 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 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (maximum observed drug concentration in measured matrix after single dose administration) (time frame: Multiple time point up to 3 day). 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 1 Sep 2015.