HealthyPhase 1NCT02171013
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) and Dabigatran polymorph I in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) and Dabigatran 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
- Apr 2006to Jul 2006
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- 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 ≥65 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 16Show 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)
- 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
About this study
Official title: Bioequivalence of Two Different Drug Product Batches of 150 mg of 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 Study)
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
- Conditions
- Healthy
- Being tested
- Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%), Dabigatran polymorph I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)Drug
Dabigatran polymorph IDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate batch A | Experimental | Not described Receives: Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) |
| Dabigatran etexilate batch B | Experimental | Not described Receives: Drug: Dabigatran 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 (AUCt1-t2)
Measured: t1 = 0 and t2 = 24, 48, 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 73
Change from baseline in vital signs (blood pressure, pulse rate)
Measured: Baseline, day 73
Change from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline, day 73
Change from baseline in clinical laboratory tests
Measured: Baseline, day 73
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to day 73
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startApr 2006
- Primary completionJul 2006
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
- NCT02171013
- Sponsor's protocol ID
- 1160.56
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Different Drug Product Batches of 150 mg of 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 Study)
- ClinicalTrials.gov ID
- NCT02171013
- Acronym / sponsor ID
- 1160.56
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2006 (actual)
- First posted
- 23 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 drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate batch A | Experimental | Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) |
| Dabigatran etexilate batch B | Experimental | Drug: Dabigatran polymorph I |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older 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 ≥65 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 (16 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 polymorph I (≈ 83%) and polymorph II (≈17%) | Drug | Dabigatran etexilate batch A |
| Dabigatran polymorph I | Drug | Dabigatran etexilate batch B |
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 (AUCt1-t2)
Time frame: t1 = 0 and t2 = 24, 48, 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 73
Change from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline, day 73
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline, day 73
Change from baseline in clinical laboratory tests
Time frame: Baseline, day 73
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 73
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 73
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 23 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 polymorph I (≈ 83%) and polymorph II (≈17%) and Dabigatran 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 4 inclusion and 16 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 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 23 Jun 2014.