HealthyPhase 1NCT02171611

Bioavailability of Different Applications of Dabigatran in Healthy Volunteers

A Phase 1 study testing Dabigatran etexilate pellets, Dabigatran etexilate powder and Dabigatran etexilate capsule in people with Healthy, run by Boehringer Ingelheim.

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

To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran etexilate pellets, Dabigatran etexilate powder and Dabigatran etexilate capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Mar 2009to May 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Age ≥18 and age ≤50 years
BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Who cannot join

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts

Show all 26Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which could reasonably influence the results of the trial (especially unspecific inducing agents like St. John´s wort (Hypericum perforatum) or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that was of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsade de Pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
For female subjects:
Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were to be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
Lactation
Intake of medication, which influences the blood clotting, i.e. acetylsalicylic acid, oral vitamin K antagonists etc.

About this study

Official title: Relative Bioavailability of Dabigatran After Administration of Different Application Forms of a Single Oral Dose of 150 mg Dabigatran Etexilate (Capsule, Powder for Reconstitution Into Solution, Pellets on Food) in Healthy Male and Female Volunteers (an Open-label, Randomised, Three-way Crossover, Clinical Phase I Study)

Conditions: Healthy
Being tested: Dabigatran etexilate pellets, Dabigatran etexilate powder, Dabigatran etexilate capsule

What participants receive

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

Dabigatran etexilate pelletsDrug
Dabigatran etexilate powderDrug
Dabigatran etexilate capsuleDrug

Study groups in NCT02171611
Study group	Role	What they receive
Dabigatran etexilate pellets	Experimental	Not described Receives: Drug: Dabigatran etexilate pellets
Dabigatran etexilate powder	Experimental	Not described Receives: Drug: Dabigatran etexilate powder
Dabigatran etexilate capsule	Active comparator	Not described Receives: Drug: Dabigatran etexilate capsule

What is being measured

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

AUC0-inf for Total Dabigatran
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
AUC0-inf for Free Dabigatran
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Cmax for Total Dabigatran
Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Cmax for Free Dabigatran
Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Secondary outcomes (17)

AUC0-tz for Total Dabigatran
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
AUC0-tz for Free Dabigatran
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Tmax for Total Dabigatran
Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Tmax for Free Dabigatran
Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
λz for Total Dabigatran
Terminal rate constant in plasma (λz) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
λz for Free Dabigatran
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
t1/2 for Total Dabigatran
Terminal half-life of the analyte in plasma (t1/2) for total dabigatran
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
t1/2 for Free Dabigatran
Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
MRTpo for Total Dabigatran
Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
MRTpo for Free Dabigatran
Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
CL/F for Total Dabigatran
Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
CL/F for Free Dabigatran
Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Vz/F for Total Dabigatran
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Vz/F for Free Dabigatran
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.
Measured: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.
Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.
There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests.
Measured: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Percentage of Participants With Drug-related Adverse Events
Percentage of participants with investigator defined drug-releated Adverse events.
Measured: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Assessment of Tolerability by Investigator.
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.
Measured: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

Timeline

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

Mar 2009May 2009

First posted24 Jun 2014 (estimated)
Study startMar 2009
Primary completionMay 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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02171611
Sponsor's protocol ID: 1160.87
Status last verified: Apr 2017
First submitted: 20 Jun 2014
Last updated: 23 May 2017
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Dabigatran After Administration of Different Application Forms of a Single Oral Dose of 150 mg Dabigatran Etexilate (Capsule, Powder for Reconstitution Into Solution, Pellets on Food) in Healthy Male and Female Volunteers (an Open-label, Randomised, Three-way Crossover, Clinical Phase I Study)
ClinicalTrials.gov ID: NCT02171611
Acronym / sponsor ID: 1160.87
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2009 (actual)
First posted: 24 Jun 2014 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dabigatran etexilate pellets	Experimental	Drug: Dabigatran etexilate pellets
Dabigatran etexilate powder	Experimental	Drug: Dabigatran etexilate powder
Dabigatran etexilate capsule	Active comparator	Drug: Dabigatran etexilate capsule

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Age ≥18 and age ≤50 years
BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Key exclusion criteria (26 listed)

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

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
Dabigatran etexilate pellets	Drug	Dabigatran etexilate pellets
Dabigatran etexilate powder	Drug	Dabigatran etexilate powder
Dabigatran etexilate capsule	Drug	Dabigatran etexilate capsule

Primary outcome

AUC0-inf for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.
AUC0-inf for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.
Cmax for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.
Cmax for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran

17 secondary outcomes

AUC0-tz for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
AUC0-tz for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Tmax for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Tmax for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
λz for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
λz for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
t1/2 for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
t1/2 for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
MRTpo for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
MRTpo for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
CL/F for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
CL/F for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Vz/F for Total Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Vz/F for Free Dabigatran
Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.
Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Percentage of Participants With Drug-related Adverse Events
Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Assessment of Tolerability by Investigator.
Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A/B/C	5	5
A/C/B	5	5
B/A/C	5	5
B/C/A	5	5
C/A/B	5	5
C/B/A	5	5

Primary outcome: AUC0-inf for Total Dabigatran

Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: ng(nanogram)*h(hour)/mL(milliliter)

Measure	Dabigatran Etexilate 150 mg Capsule: Reference (A) n = 30	Dabigatran Etexilate 150 mg Pellets: Test 1 (B) n = 30	Dabigatran Etexilate 150 mg Powder: Test 2 (C) n = 30
Value	599 (93.3)	1050 (33.8)	928 (32.8)

Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B): Ratio of adjusted geometric means: 175.14 (90% CI 141.904 to 216.149)
Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C): Ratio of adjusted geometric means: 154.84 (90% CI 127.425 to 188.161)

Population analysed: PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax.

Primary outcome: AUC0-inf for Free Dabigatran

Measure	Dabigatran Etexilate 150 mg Capsule: Reference (A) n = 30	Dabigatran Etexilate 150 mg Pellets: Test 1 (B) n = 30	Dabigatran Etexilate 150 mg Powder: Test 2 (C) n = 30
Value	464 (97.3)	815 (40)	734 (38.2)

Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B): Ratio of adjusted geometric means in %: 175.4 (90% CI 141.924 to 216.772)
Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C): Ratio of adjusted geometric means in %: 158.12 (90% CI 130.052 to 192.255)

Population analysed: pharmacokinetic per-protocol set

Primary outcome: Cmax for Total Dabigatran

Measure	Dabigatran Etexilate 150 mg Capsule: Reference (A) n = 30	Dabigatran Etexilate 150 mg Pellets: Test 1 (B) n = 30	Dabigatran Etexilate 150 mg Powder: Test 2 (C) n = 30
Value	74.6 (110)	139 (37.8)	124 (37)

Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B): Ratio of adjusted geometric means: 186.94 (90% CI 147.659 to 236.665)
Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C): Ratio of adjusted geometric means in %: 166.59 (90% CI 133.221 to 208.326)

Population analysed: pharmacokinetic per-protocol set

Primary outcome: Cmax for Free Dabigatran

Measure	Dabigatran Etexilate 150 mg Capsule: Reference (A) n = 30	Dabigatran Etexilate 150 mg Pellets: Test 1 (B) n = 30	Dabigatran Etexilate 150 mg Powder: Test 2 (C) n = 30
Value	61.5 (110)	112 (40.4)	103 (40.7)

Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B): Ratio of adjusted geometric means in %: 181.6 (90% CI 145.428 to 226.776)
Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C): Ratio of adjusted geometric means in %: 166.83 (90% CI 134.25 to 207.328)

Population analysed: pharmacokinetic per-protocol set

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate 150 mg Capsule: Reference (A)	0 of 30 (0%)	2 of 30 (6.7%)	Not reported
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)	0 of 30 (0%)	7 of 30 (23.3%)	Not reported
Dabigatran Etexilate 150 mg Powder: Test 2 (C)	0 of 30 (0%)	8 of 30 (26.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran etexilate pellets, Dabigatran etexilate powder and Dabigatran etexilate capsule in people with Healthy, run by Boehringer Ingelheim.

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 4 inclusion and 26 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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 25 Apr 2017). 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?

AUC0-inf for Total Dabigatran (time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.). The study lists 4 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 NCT02171611.

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 23 May 2017.