HealthyPhase 1NCT02171481
Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate polymorph II and Dabigatran etexilate polymorph I in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran etexilate polymorph II and Dabigatran etexilate polymorph I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Aug 2008
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 ≥60 and ≤85 years
- BMI ≥18.5 and BMI ≤32.0 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
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Clinically relevant surgery of gastrointestinal tract
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Any relevant bleeding history
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 19Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- 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 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
- Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
- Alcohol abuse (more than 60 g/day for men and more than 40 g/day for women)
- 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 is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Planned surgeries within four weeks following the end-of study examination
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration
- Male subjects who do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
About this study
Official title: Bioequivalence of Two Different Polymorphs of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate polymorph II, Dabigatran etexilate polymorph I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilate polymorph IIDrug
Dabigatran etexilate polymorph IDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate polymorph II | Experimental | Not described Receives: Drug: Dabigatran etexilate polymorph II |
| Dabigatran etexilate polymorph I | Active comparator | Not described Receives: Drug: Dabigatran etexilate polymorph I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 72 hours after drug administration
Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax)
Measured: Up to 72 hours after drug administration
Secondary outcomes (16)
Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 72 hours after drug administration
Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax)
Measured: Up to 72 hours after drug administration
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)
Measured: Up to 72 hours after drug administration
Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours (AUCt1-t2)
Measured: 24, 48 and 72 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 72 hours after drug administration
Terminal rate constant in plasma (λz)
Measured: Up to 72 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 72 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: Up to 72 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Measured: Up to 72 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F )
Measured: Up to 72 hours after drug administration
Change from baseline in physical examination
Measured: Baseline, day 68
Change from baseline in vital signs (blood pressure, pulse rate)
Measured: Baseline, day 68
Change from baseline in 12-lead electrocardiogram
Measured: Baseline, day 68
Change from baseline in clinical laboratory tests
Measured: Baseline, day 68
Number of Participants with Serious and Non-Serious Adverse Events
Measured: up to day 68
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Day 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMay 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171481
- Sponsor's protocol ID
- 1160.66
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Different Polymorphs of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
- ClinicalTrials.gov ID
- NCT02171481
- Acronym / sponsor ID
- 1160.66
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 24 Jun 2014 (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.
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate polymorph II | Experimental | Drug: Dabigatran etexilate polymorph II |
| Dabigatran etexilate polymorph I | Active comparator | Drug: Dabigatran etexilate polymorph I |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 ≥60 and ≤85 years
- BMI ≥18.5 and BMI ≤32.0 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 (19 listed)
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Clinically relevant surgery of gastrointestinal tract
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Any relevant bleeding history
- 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 etexilate polymorph II | Drug | Dabigatran etexilate polymorph II |
| Dabigatran etexilate polymorph I | Drug | Dabigatran etexilate polymorph I |
Primary outcome
Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 72 hours after drug administration
Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax)
Time frame: Up to 72 hours after drug administration
16 secondary outcomes
Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 72 hours after drug administration
Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax)
Time frame: Up to 72 hours after drug administration
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)
Time frame: Up to 72 hours after drug administration
Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours (AUCt1-t2)
Time frame: 24, 48 and 72 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 72 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: Up to 72 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: Up to 72 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: Up to 72 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: Up to 72 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F )
Time frame: Up to 72 hours after drug administration
Change from baseline in physical examination
Time frame: Baseline, day 68
Change from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline, day 68
Change from baseline in 12-lead electrocardiogram
Time frame: Baseline, day 68
Change from baseline in clinical laboratory tests
Time frame: Baseline, day 68
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: up to day 68
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 68
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 24 Jun 2014.
- 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 polymorph II and Dabigatran etexilate polymorph I 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 5 inclusion and 19 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 24 Jun 2014. 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?
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?
Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 72 hours after drug administration). 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 24 Jun 2014.