HealthyPhase 1NCT02171507
Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate and Diclofenac in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran etexilate and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 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 18 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, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
- Age ≥18 and ≤55 years
- Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Who cannot join
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder including history of gastrointestinal erosions and ulcer or acute blood coagulation defect
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 23Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the objectives of 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 two months 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
- Subjects with abnormal thrombocyte counts and any relevant deviation in the assessment of platelet function (PFA test) must be excluded
- Inability to comply with dietary regimen of study centre
- Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either the oral contraceptives since at least two months and the double barrier method, i.e. intrauterine device with spermicide and condom for the male partner
- Male subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after 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)
- Planned surgeries within four weeks following the end-of study examination
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Vulnerable subjects (e.g. persons kept in detention).
About this study
Official title: Relative Bioavailability of Dabigatran and Diclofenac After 150 mg b.i.d. Dabigatran Etexilate and Diclofenac at 50 mg Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple- Dose, Three-way Crossover Study)
To investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
DiclofenacDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate | Active comparator | Not described Receives: Drug: Dabigatran etexilate |
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
| Dabigatran etexilate + diclofenac | Experimental | Not described Receives: Drug: Dabigatran etexilate; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss on Day 4 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)
Measured: from pre-dose up to 72 hours post-dose
Cmax,ss (maximum concentration of dabigatran in plasma at steady state)
Measured: from pre-dose up to 72 hours post-dose
Cmax (maximal concentration of diclofenac in plasma)
Measured: from pre-dose up to 72 hours post-dose
AUC0-infinity (area under the concentration-time curve of diclofenac in plasma extrapolated to infinity)
Measured: from pre-dose up to 72 hours post-dose
aPTT (activated partial thromboplastin time) and ECT (Ecarin clotting time) with and without diclofenac
Measured: from pre-dose up to 72 hours post-dose
AUERτ,ss (area under the effect ratio-time curve of dabigatran in plasma at steady state over a uniform dosing interval τ)
Measured: from pre-dose up to 72 hours post-dose
ERmax,ss (maximal effect ratio of dabigatran in plasma at steady state)
Measured: from pre-dose up to 72 hours post-dose
Secondary outcomes (21)
AUC0-tz,ss (area under the concentration-time curve of dabigatran in plasma from the time point 0 after the last dose at steady state to the last quantifiable dabigatran plasma concentration within the uniform dosing interval τ)
Measured: from pre-dose up to 72 hours post-dose
tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)
Measured: from pre-dose up to 72 hours post-dose
tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state on Day 4)
Measured: from pre-dose up to 72 hours post-dose
CL/Fss (apparent clearance of dabigatran in the plasma at steady state after extravascular multiple dose administration)
Measured: from pre-dose up to 72 hours post-dose
CLR,ss (renal clearance of dabigatran at steady state determined over the dosing interval τ)
Measured: from pre-dose up to 72 hours post-dose
C min,ss (minimum measured concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)
Measured: from pre-dose up to 72 hours post-dose
tmin,ss (time from last dosing to the minimum concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)
Measured: from pre-dose up to 72 hours post-dose
Cpre,ss (pre-dose concentration of dabigatran in plasma at steady state immediately before administration of the next dose)
Measured: from pre-dose up to 72 hours post-dose
MRTp.o.,ss (mean residence time of dabigatran in the body at steady state after oral administration)
Measured: from pre-dose up to 72 hours post-dose
Vz/Fss (apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration)
Measured: from pre-dose up to 72 hours post-dose
Aeτ,ss (amount of dabigatran that is eliminated in urine at steady state over a uniform dosing interval τ)
Measured: 0 to 12 h and 12 to 24 h after administration on day 4
feτ,ss (fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ)
Measured: 0 to 12 h and 12 to 24 h after administration on day 4
AUC0-tz (area under the concentration-time curve of diclofenac and 4´- hydroxydiclofenac in plasma over the time interval 0 to the last quantifiable analyte plasma concentration after single dose administration)
Measured: from pre-dose up to 72 hours post-dose
tz (time of last measurable concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)
Measured: from pre-dose up to 72 hours post-dose
%AUCtz-infinity (percentage of the AUC0-infinity that is obtained by extrapolation) for diclofenac and 4´- hydroxydiclofenac
Measured: from pre-dose up to 72 hours post-dose
tmax (time from dosing to the maximum concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)
Measured: from pre-dose up to 72 hours post-dose
λz (terminal rate constant in plasma after a single dose) for diclofenac and 4´- hydroxydiclofenac
Measured: from pre-dose up to 72 hours post-dose
t1/2 (terminal half-life of diclofenac and 4´- hydroxydiclofenac in plasma after a single dose)
Measured: from pre-dose up to 72 hours post-dose
MRTp.o. (mean residence time of diclofenac and 4´- hydroxydiclofenac in the body after single dose oral administration)
Measured: from pre-dose up to 72 hours post-dose
CL/F (apparent clearance of diclofenac and 4´- hydroxydiclofenac in the plasma after extravascular single dose administration)
Measured: from pre-dose up to 72 hours post-dose
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular dose) for diclofenac and 4´- hydroxydiclofenac
Measured: from pre-dose up to 72 hours post-dose
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 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
- None (open label)
- Enrolment
- 24 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
- NCT02171507
- Sponsor's protocol ID
- 1160.7
- 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
- Relative Bioavailability of Dabigatran and Diclofenac After 150 mg b.i.d. Dabigatran Etexilate and Diclofenac at 50 mg Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple- Dose, Three-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02171507
- Acronym / sponsor ID
- 1160.7
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2006 (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 investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate | Active comparator | Drug: Dabigatran etexilate |
| Diclofenac | Active comparator | Drug: Diclofenac |
| Dabigatran etexilate + diclofenac | Experimental | Drug: Dabigatran etexilate, Drug: Diclofenac |
Who may qualify
- Ages
- 18 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, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
- Age ≥18 and ≤55 years
- Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Key exclusion criteria (23 listed)
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder including history of gastrointestinal erosions and ulcer or acute blood coagulation defect
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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 | Drug | Dabigatran etexilate, Dabigatran etexilate + diclofenac |
| Diclofenac | Drug | Dabigatran etexilate + diclofenac, Diclofenac |
Primary outcome
AUCτ,ss on Day 4 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)
Time frame: from pre-dose up to 72 hours post-dose
Cmax,ss (maximum concentration of dabigatran in plasma at steady state)
Time frame: from pre-dose up to 72 hours post-dose
Cmax (maximal concentration of diclofenac in plasma)
Time frame: from pre-dose up to 72 hours post-dose
AUC0-infinity (area under the concentration-time curve of diclofenac in plasma extrapolated to infinity)
Time frame: from pre-dose up to 72 hours post-dose
aPTT (activated partial thromboplastin time) and ECT (Ecarin clotting time) with and without diclofenac
Time frame: from pre-dose up to 72 hours post-dose
AUERτ,ss (area under the effect ratio-time curve of dabigatran in plasma at steady state over a uniform dosing interval τ)
Time frame: from pre-dose up to 72 hours post-dose
ERmax,ss (maximal effect ratio of dabigatran in plasma at steady state)
Time frame: from pre-dose up to 72 hours post-dose
21 secondary outcomes
AUC0-tz,ss (area under the concentration-time curve of dabigatran in plasma from the time point 0 after the last dose at steady state to the last quantifiable dabigatran plasma concentration within the uniform dosing interval τ)
Time frame: from pre-dose up to 72 hours post-dose
tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)
Time frame: from pre-dose up to 72 hours post-dose
tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state on Day 4)
Time frame: from pre-dose up to 72 hours post-dose
CL/Fss (apparent clearance of dabigatran in the plasma at steady state after extravascular multiple dose administration)
Time frame: from pre-dose up to 72 hours post-dose
CLR,ss (renal clearance of dabigatran at steady state determined over the dosing interval τ)
Time frame: from pre-dose up to 72 hours post-dose
C min,ss (minimum measured concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)
Time frame: from pre-dose up to 72 hours post-dose
tmin,ss (time from last dosing to the minimum concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)
Time frame: from pre-dose up to 72 hours post-dose
Cpre,ss (pre-dose concentration of dabigatran in plasma at steady state immediately before administration of the next dose)
Time frame: from pre-dose up to 72 hours post-dose
MRTp.o.,ss (mean residence time of dabigatran in the body at steady state after oral administration)
Time frame: from pre-dose up to 72 hours post-dose
Vz/Fss (apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration)
Time frame: from pre-dose up to 72 hours post-dose
Aeτ,ss (amount of dabigatran that is eliminated in urine at steady state over a uniform dosing interval τ)
Time frame: 0 to 12 h and 12 to 24 h after administration on day 4
feτ,ss (fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ)
Time frame: 0 to 12 h and 12 to 24 h after administration on day 4
AUC0-tz (area under the concentration-time curve of diclofenac and 4´- hydroxydiclofenac in plasma over the time interval 0 to the last quantifiable analyte plasma concentration after single dose administration)
Time frame: from pre-dose up to 72 hours post-dose
tz (time of last measurable concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)
Time frame: from pre-dose up to 72 hours post-dose
%AUCtz-infinity (percentage of the AUC0-infinity that is obtained by extrapolation) for diclofenac and 4´- hydroxydiclofenac
Time frame: from pre-dose up to 72 hours post-dose
tmax (time from dosing to the maximum concentration of diclofenac and 4´- hydroxydiclofenac in plasma following a single dose)
Time frame: from pre-dose up to 72 hours post-dose
λz (terminal rate constant in plasma after a single dose) for diclofenac and 4´- hydroxydiclofenac
Time frame: from pre-dose up to 72 hours post-dose
t1/2 (terminal half-life of diclofenac and 4´- hydroxydiclofenac in plasma after a single dose)
Time frame: from pre-dose up to 72 hours post-dose
MRTp.o. (mean residence time of diclofenac and 4´- hydroxydiclofenac in the body after single dose oral administration)
Time frame: from pre-dose up to 72 hours post-dose
CL/F (apparent clearance of diclofenac and 4´- hydroxydiclofenac in the plasma after extravascular single dose administration)
Time frame: from pre-dose up to 72 hours post-dose
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular dose) for diclofenac and 4´- hydroxydiclofenac
Time frame: from pre-dose up to 72 hours post-dose
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.
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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 and Diclofenac 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 23 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?
AUCτ,ss on Day 4 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval) (time frame: from pre-dose up to 72 hours post-dose). The study lists 7 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; AzTrials last refreshed its copy on 8 Nov 2026.