HealthyPhase 1NCT01290757

Bioequivalence of Two Different Capsule Types of Dabigatran

A Phase 1 study testing Dabigatran etexilate in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches. The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteGermany
Study dates: Jan 2011to Apr 2011
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 21 to 55 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age =21 and = 55 years
Body Mass Index (BMI) =18.5 and BMI = 29.9 kg/m^2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Who cannot join

Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Clinically relevant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug
Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections

Show all 13Show fewer

History of allergy/hypersensitivity (including drug allergy in particular to study drug or its excipients) which is deemed relevant to the trial as judged by the investigator
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Alcohol abuse (more than 20 g/day)
Drug abuse
Any laboratory value outside the reference range that is of clinical relevance (especially hemoglobin, thrombocytes, prothrombin time (PT) and Activated Partial Thromboplastin Time (Measure of the clotting time) (aPTT) or positive drug or virus screening
Planned surgeries within four weeks following the end-of study examination
Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding within 14 days before or after end-of study examination

Trial locations and contacts

1 site in 1 country.

Germany1 site

1160.117.1 Boehringer Ingelheim Investigational Site
Mannheim

Other trials in Germany

About this study

Official title: Bioequivalence of Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)

The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.

Conditions: Healthy
Being tested: Dabigatran etexilate

What participants receive

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

Dabigatran etexilateDrug
150 mg Capsugel (T)
Dabigatran etexilateDrug
150 mg Qualicaps (R)

Study groups in NCT01290757
Study group	Role	What they receive
Dabigatran etexilate 150 mg (T)	Experimental	Capsugel (T), oral administration Receives: Drug: Dabigatran etexilate
Dabigatran etexilate 150 mg (R)	Experimental	Qualicaps (R), oral administration Receives: Drug: Dabigatran etexilate

What is being measured

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

Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours
Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours

Secondary outcomes (4)

Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.
Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours
AUC0-tz of Free Dabigatran.
Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours
Cmax of Free Dabigatran in Plasma.
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours
AUC0-∞ of Free Dabigatran.
Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Measured: 60 hours

Timeline

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

Jan 2011Apr 2011

First posted7 Feb 2011 (estimated)
Study startJan 2011
Primary completionApr 2011

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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290757
Sponsor's protocol ID: 1160.117
Other IDs: 2010-022966-28
Status last verified: Dec 2013
First submitted: 2 Feb 2011
Last updated: 19 May 2014
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
ClinicalTrials.gov ID: NCT01290757
Acronym / sponsor ID: 1160.117
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Apr 2011 (actual)
First posted: 7 Feb 2011 (estimated)
Results: Posted 29 Jun 2012

Clinical summary

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

The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

Study design

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

Arm	Type	Receives
Dabigatran etexilate 150 mg (T)	Experimental	Drug: Dabigatran etexilateCapsugel (T), oral administration
Dabigatran etexilate 150 mg (R)	Experimental	Drug: Dabigatran etexilateQualicaps (R), oral administration

Who may qualify

Ages: 21 to 55 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age =21 and = 55 years
Body Mass Index (BMI) =18.5 and BMI = 29.9 kg/m^2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Key exclusion criteria (13 listed)

Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Clinically relevant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug
Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies
History of relevant orthostatic hypotension, fainting spells or blackouts

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 etexilate150 mg Capsugel (T)	Drug	Dabigatran etexilate 150 mg (T)
Dabigatran etexilate150 mg Qualicaps (R)	Drug	Dabigatran etexilate 150 mg (R)

Primary outcome

Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
Time frame: 60 hours
Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma
Time frame: 60 hours
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.

4 secondary outcomes

Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.
Time frame: 60 hours
AUC0-tz of Free Dabigatran.
Time frame: 60 hours
Cmax of Free Dabigatran in Plasma.
Time frame: 60 hours
AUC0-∞ of Free Dabigatran.
Time frame: 60 hours

Results and safety

Results posted to the registry on 29 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel	90	88
Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps	90	88

Primary outcome: Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran

Time frame: 60 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Capsugel n = 179	Qualicaps n = 180
Value	1147.64 (32.32)	908.48 (49.83)

Capsugel vs Qualicaps: Upper 95% CI of the linearized criterion: -0.082, Mixed Models Analysis
Capsugel vs Qualicaps: Adjusted geometric mean ratio (%): 126.33 (90% CI 119.45 to 133.60), Mixed Models Analysis

Population analysed: This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence.

Primary outcome: Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma

Time frame: 60 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Capsugel n = 179	Qualicaps n = 180
Value	134.44 (31.10)	107.13 (49.67)

Capsugel vs Qualicaps: Upper 95% CI of the linearized criterion: -0.085, Mixed Models Analysis
Capsugel vs Qualicaps: Adjusted geometric mean ratio (%): 125.49 (90% CI 118.69 to 132.67), Mixed Models Analysis

Population analysed: PKS

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Qualicaps	0 of 180 (0%)	37 of 180 (20.6%)	Not reported
Capsugel	0 of 180 (0%)	34 of 180 (18.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Dabigatran etexilate in people with Healthy, run by Boehringer Ingelheim 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 4 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 19 May 2014. 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 29 Jun 2012). 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 Curve 0 to tz (AUC0-tz) of Total Dabigatran (time frame: 60 hours). 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?

On the ClinicalTrials.gov record for NCT01290757.

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 19 May 2014.