Therapeutic EquivalencyPhase 1NCT01436526

Bioequivalence Study in Healthy Subjects, 25 mg Tablets Rivaroxaban Versus 110 mg Tablet Rivaroxaban

A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Therapeutic Equivalency, run by Bayer at 1 site in Germany.

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

The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Therapeutic Equivalency
What is being tested?: Rivaroxaban (Xarelto, BAY59-7939)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteGermany
Study dates: Aug 2009to Sep 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects
18 to 45 years of age
Body mass index (BMI) between 18 and 30 kg/m2

Who cannot join

Conspicuous findings (medical history, screening)
History of relevant diseases (internal organs, central nervous system or other organs)
Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
Febrile illness within 1 week before the start of the study
History of severe allergies, non-allergic drug reactions, or multiple drug allergies
Hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
Known coagulation disorders, known disorders with increased bleeding risk, known sensitivity to common causes of bleeding

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Mönchengladbach, North Rhine-Westphalia, 41061

Other trials in Germany

About this study

Official title: Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 2x5 mg Tablets Rivaroxaban Versus 1x10 mg Tablet Rivaroxaban Under Fasted Condition in Healthy Subjects

The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.

Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.

The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.

Conditions: Therapeutic Equivalency
Being tested: Rivaroxaban (Xarelto, BAY59-7939)
Keywords: Bioequivalence

What participants receive

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

Rivaroxaban (Xarelto, BAY59-7939)Drug
Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
Rivaroxaban (Xarelto, BAY59-7939)Drug
Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)

Study groups in NCT01436526
Study group	Role	What they receive
Rivaroxaban (Xarelto, BAY59-7939) first 25 mg, then 110 mg	Experimental	Single oral dose of rivaroxaban administered under fasting conditions 25 mg tablet in first intervention period and 110 mg tablet in second intervention period (after washout period) Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban (Xarelto, BAY59-7939) first 110 mg, then 25 mg	Experimental	Single oral dose of rivaroxaban administered under fasting conditions 110 mg tablet in first intervention period and 25 mg tablet in second intervention period (after washout period) Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)

What is being measured

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

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Secondary outcomes (5)

Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Mean Residence Time (MRT)
The mean residence time is the average time that the molecules introduced into the body stay in the body.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Half-life Associated With the Terminal Slope (t½)
Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.
Measured: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Timeline

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

Aug 2009Sep 2009

First posted19 Sep 2011 (estimated)
Study startAug 2009
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Therapeutic EquivalencyStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01436526
Sponsor's protocol ID: 14588
Other IDs: 2009-013032-20, 2009
Status last verified: Apr 2015
First submitted: 16 Sep 2011
Last updated: 22 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 2x5 mg Tablets Rivaroxaban Versus 1x10 mg Tablet Rivaroxaban Under Fasted Condition in Healthy Subjects
ClinicalTrials.gov ID: NCT01436526
Acronym / sponsor ID: 14588
Conditions: Therapeutic Equivalency
Keywords: Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study start: Aug 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 19 Sep 2011 (estimated)
Results: Posted 22 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rivaroxaban (Xarelto, BAY59-7939) first 25 mg, then 110 mg	Experimental	Drug: Rivaroxaban (Xarelto, BAY59-7939)Single oral dose of rivaroxaban administered under fasting conditions 25 mg tablet in first intervention period and 110 mg tablet in second intervention period (after washout period)
Rivaroxaban (Xarelto, BAY59-7939) first 110 mg, then 25 mg	Experimental	Drug: Rivaroxaban (Xarelto, BAY59-7939)Single oral dose of rivaroxaban administered under fasting conditions 110 mg tablet in first intervention period and 25 mg tablet in second intervention period (after washout period)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male subjects
18 to 45 years of age
Body mass index (BMI) between 18 and 30 kg/m2

Key exclusion criteria (7 listed)

Conspicuous findings (medical history, screening)
History of relevant diseases (internal organs, central nervous system or other organs)
Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
Febrile illness within 1 week before the start of the study
History of severe allergies, non-allergic drug reactions, or multiple drug allergies

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 (Xarelto, BAY59-7939)Single oral dose of rivaroxaban administered under fasting conditions 25 mg tablet in first intervention period and 110 mg tablet in second intervention period (after washout period)	Drug	Rivaroxaban (Xarelto, BAY59-7939) first 25 mg, then 110 mg
Rivaroxaban (Xarelto, BAY59-7939)Single oral dose of rivaroxaban administered under fasting conditions 110 mg tablet in first intervention period and 25 mg tablet in second intervention period (after washout period)	Drug	Rivaroxaban (Xarelto, BAY59-7939) first 110 mg, then 25 mg

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

5 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Mean Residence Time (MRT)
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
Half-life Associated With the Terminal Slope (t½)
Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Results and safety

Results posted to the registry on 22 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rivaroxaban (Xarelto, BAY59-7939) First 25 mg, Then 110 mg	14	14
Rivaroxaban (Xarelto, BAY59-7939) First 110 mg, Then 25 mg	14	14

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation

Time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration. Geometric mean (Geometric Coefficient of Variation). Unit: µg*hr/L

Measure	Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg n = 26	Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg n = 26
Value	1374 (29.3)	1268 (30.7)

Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg vs Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg: LS-Mean Ratio, Percent: 108.35 (90% CI 101.59 to 115.57), p = 0.0438, ANOVA

Population analysed: N=26 valid for pharmacokinetic analysis

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation

Measure	Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg n = 26	Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg n = 26
Value	1354 (29.8)	1252 (31.6)

Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg vs Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg: LS-Mean Ratio, Percent: 108.19 (90% CI 101.31 to 115.54), p = 0.0514, ANOVA

Population analysed: N=26 valid for pharmacokinetic analysis

Primary outcome: Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation

Measure	Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg n = 26	Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg n = 26
Value	179.8 (31.1)	161.1 (38.7)

Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg vs Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg: LS-Mean Ratio, Percent: 111.64 (90% CI 101.14 to 123.23), p = 0.0685, ANOVA

Population analysed: N=26 valid for pharmacokinetic analysis

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)	0 of 27 (0%)	6 of 27 (22.2%)	Not reported
Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)	0 of 27 (0%)	6 of 27 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 (Xarelto, BAY59-7939) in people with Therapeutic Equivalency, 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 3 inclusion and 7 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 22 Apr 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 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?

Yes. Results are posted in the registry (first posted 22 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation (time frame: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post 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?

On the ClinicalTrials.gov record for NCT01436526.

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 22 Apr 2015.