Healthy VolunteersPhase 1NCT04727021
A Trial to Learn How Much Rivaroxaban Gets Into the Blood When Taken in Different Forms and How Safe They Are in Healthy Men
A Phase 1 study testing 20 mg tablet rivaroxaban and 20 mg rivaroxaban, granules for oral suspension in people with Healthy Volunteers, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat venous thromboembolic disease, also known as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These clots or a piece of a clot can break free and move around the body in the blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 20 mg tablet rivaroxaban and 20 mg rivaroxaban, granules for oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2017to 27 Oct 2017
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects.
- Age: 18 to 55 years (inclusive) at the screening examination/visit.
- Race: White (Note: Clinical Data Interchange Standards Consortium definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White (Food and Drug Administration [FDA]).
- Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
- Ability to understand and follow instructions.
Who cannot join
- 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
- Known or suspected liver disorders and bile secretion/flow
- Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening
- Personal or familial history of genetically muscular diseases
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract- allergic asthma, allergies requiring therapy with corticosteroids, urticaria) or significant non-allergic drug reactions
Show all 13Show fewer
- Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS (QRS interval in ECG) complex over 120 msec or of the QTc-interval over 450 msec at the first screening visit
- Presence or history of arrhythmic disturbances; or known congenital QT (QT interval in ECG) prolongation
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 50 or above 90 beats/ min
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061
About this study
Official title: Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 20 mg Granules for Oral Suspension Rivaroxaban Versus 20 mg Tablets Rivaroxaban Under Fed Condition in Healthy Subjects
Researchers are looking for a better way to treat venous thromboembolic disease, also known as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These clots or a piece of a clot can break free and move around the body in the blood vessels. These clots can block small blood vessels, causing other conditions like high blood pressure, heart attack, and stroke.
Before people with a medical condition can take an approved treatment in a new form, researchers do trials in healthy participants. This helps them understand how the new form acts in the body and to better understand its safety.
Read more
In this trial, the researchers will compare how much of the trial treatment gets into the blood when taken in 2 different forms in a small number of participants. The trial will include about 30 men who are aged 18 to 55.
In this trial, there will be 2 groups of participants. The participants will take rivaroxaban in the current tablet form and in a new liquid form 1 time. This was a "crossover" trial. In a crossover trial, all the participants will take both forms of the treatments, but in a different order.
During the trial, the participants will stay at their trial site 2 times for 5 days. But, the participants can be in the trial for up to about 6 weeks. During the trial, the doctors will take blood and urine samples and check the participants' heart health using an electrocardiogram (ECG) and measure the blood pressure. The participants will also answer questions about how they are feeling, if they have any medical problems, and about any medications they are taking.
- Conditions
- Healthy Volunteers
- Being tested
- 20 mg tablet rivaroxaban, 20 mg rivaroxaban, granules for oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg tablet rivaroxabanDrug
Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions
20 mg rivaroxaban, granules for oral suspensionDrug
Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Single oral dose of a 20 mg tablet rivaroxaban | Experimental | 2-way crossover: The subjects will receive the following treatments in a randomized order:
* Treatment A: Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions
* Treatment B: Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. Receives: Drug: 20 mg tablet rivaroxaban |
| Treatment B: Single oral dose of 20 mg rivaroxaban, granules | Experimental | 2-way crossover: The subjects will receive the following treatments in a randomized order:
* Treatment A: Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions
* Treatment B: Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. Receives: Drug: 20 mg rivaroxaban, granules for oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
AUC = area under the concentration vs. time curve from zero to infinity after single (first) dose
Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
Measured: From pre-dose up to 72 hours after drug administration
AUC(0-tlast) of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
AUC(0-tlast) = AUC from time 0 to the last data point > lower limit of quantification (LLOQ)
Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
Measured: From pre-dose up to 72 hours after drug administration
Cmax of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
Cmax = maximum observed drug concentration in measured matrix after single dose administration
Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
Measured: From pre-dose up to 72 hours after drug administration.
Secondary outcomes (1)
Number of treatment-emergent adverse events
Adverse events occurring in the period between the signing of the informed consent and the end of the follow-up phase.
Measured: Up to 7-14 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Jul 2017
- Primary completion4 Sep 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727021
- Sponsor's protocol ID
- 19366
- Other IDs
- 2017-000609-18, 2017
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 20 mg Granules for Oral Suspension Rivaroxaban Versus 20 mg Tablets Rivaroxaban Under Fed Condition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04727021
- Acronym / sponsor ID
- 19366
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 27 Jan 2021 (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 are looking for a better way to treat venous thromboembolic disease, also known as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These clots or a piece of a clot can break free and move around the body in the blood vessels. These clots can block small blood vessels, causing other conditions like high blood pressure, heart attack, and stroke.
Before people with a medical condition can take an approved treatment in a new form, researchers do trials in healthy participants. This helps them understand how the new form acts in the body and to better understand its safety.
In this trial, the researchers will compare how much of the trial treatment gets into the blood when taken in 2 different forms in a small number of participants. The trial will include about 30 men who are aged 18 to 55.
In this trial, there will be 2 groups of participants. The participants will take rivaroxaban in the current tablet form and in a new liquid form 1 time. This was a "crossover" trial. In a crossover trial, all the participants will take both forms of the treatments, but in a different order.
During the trial, the participants will stay at their trial site 2 times for 5 days. But, the participants can be in the trial for up to about 6 weeks. During the trial, the doctors will take blood and urine samples and check the participants' heart health using an electrocardiogram (ECG) and measure the blood pressure. The participants will also answer questions about how they are feeling, if they have any medical problems, and about any medications they are taking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Single oral dose of a 20 mg tablet rivaroxaban | Experimental | Drug: 20 mg tablet rivaroxaban2-way crossover: The subjects will receive the following treatments in a randomized order: * Treatment A: Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions * Treatment B: Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. |
| Treatment B: Single oral dose of 20 mg rivaroxaban, granules | Experimental | Drug: 20 mg rivaroxaban, granules for oral suspension2-way crossover: The subjects will receive the following treatments in a randomized order: * Treatment A: Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions * Treatment B: Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects.
- Age: 18 to 55 years (inclusive) at the screening examination/visit.
- Race: White (Note: Clinical Data Interchange Standards Consortium definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White (Food and Drug Administration [FDA]).
- Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
- Ability to understand and follow instructions.
Key exclusion criteria (13 listed)
- 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
- Known or suspected liver disorders and bile secretion/flow
- Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening
- Personal or familial history of genetically muscular diseases
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
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 |
|---|---|---|
| 20 mg tablet rivaroxabanSingle oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions | Drug | Treatment A: Single oral dose of a 20 mg tablet rivaroxaban |
| 20 mg rivaroxaban, granules for oral suspensionSingle oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions. | Drug | Treatment B: Single oral dose of 20 mg rivaroxaban, granules |
Primary outcome
AUC of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
Time frame: From pre-dose up to 72 hours after drug administration
AUC = area under the concentration vs. time curve from zero to infinity after single (first) dose Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
AUC(0-tlast) of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
Time frame: From pre-dose up to 72 hours after drug administration
AUC(0-tlast) = AUC from time 0 to the last data point > lower limit of quantification (LLOQ) Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
Cmax of rivaroxaban granules for oral suspension vs. rivaroxaban tablet
Time frame: From pre-dose up to 72 hours after drug administration.
Cmax = maximum observed drug concentration in measured matrix after single dose administration Rivaroxaban Blood sampling for rivaroxaban pharmacokinetics in plasma.
1 secondary outcome
Number of treatment-emergent adverse events
Time frame: Up to 7-14 days after the last administration
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 27 Jan 2021.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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.
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 20 mg tablet rivaroxaban and 20 mg rivaroxaban, granules for oral suspension in people with Healthy Volunteers, run by Bayer at 1 site in Germany.
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 5 inclusion and 13 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 27 Jan 2021. 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 Germany. 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?
AUC of rivaroxaban granules for oral suspension vs. rivaroxaban tablet (time frame: From pre-dose up to 72 hours after drug administration). The study lists 3 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 27 Jan 2021.