HealthyPhase 1NCT02171546
Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate capsules, Quinidine sulfate tablets and Fexofenadine tablets in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate, Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp 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 capsules, Quinidine sulfate tablets and Fexofenadine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 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 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 (BP, PR), 12-lead ECG, clinical laboratory tests ;
- Age ≥18 and Age ≤55 years;
- Body Mass Index (BMI) ≥18.5 and BMI <30 kg/m2;
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation;
- If female of child-bearing potential, not be pregnant or breast feeding, nor plan to become pregnant for the duration of the study and for 2 months after receiving the last dose of study drug, and have a negative serum pregnancy test within 14 days of treatment, and prior to dosing;
- Females of child-bearing potential willing to use adequate contraception, defined as the use of hormonal (oral, injectable or implantable) or barrier method contraceptives, intrauterine device and agree to use the same method of contraception for at least 2 months after drug administration. Women who have undergone a total hysterectomy, have a history of bilateral tubal ligation or are at least 2 years post-menopausal are not considered to be of child-bearing potential.
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 23Show 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 might reasonably influence the results of the trial 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 is 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 Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
- Taking drugs which are known P-gp inhibitors or inducers (verapamil, phenothiazine antipsychotics, erythromycin, antifungal drugs or St. John´s Wort) within the last 4 weeks before screening;
- Chronic use of oral contraception containing ethinyl estradiol as the only method of contraception.
About this study
Official title: A Two-part Study to Determine the Relative Bioavailability of Dabigatran Etexilate 150 mg Bid (Capsules) With and Without 600 mg Quinidine Sulfate Tablets (Part 1) and to Measure the Effect of Quinidine as a Probe Inhibitor of P-glycoprotein on the Absorption of Fexofenadine, a Probe Substrate of P-glycoprotein (Part 2) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two Times Two-way Crossover Study)
Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate,
Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate capsules, Quinidine sulfate tablets, Fexofenadine tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilate capsulesDrug
Quinidine sulfate tabletsDrug
Fexofenadine tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate capsules | Active comparator | Not described Receives: Drug: Dabigatran etexilate capsules |
| Dabigatran etexilate capsules and quinidine sulfate tablets | Experimental | Not described Receives: Drug: Dabigatran etexilate capsules; Drug: Quinidine sulfate tablets |
| Fexofenadine tablets | Active comparator | Not described Receives: Drug: Fexofenadine tablets |
| Fexofenadine and quinidine sulfate tablets | Experimental | Not described Receives: Drug: Quinidine sulfate tablets; Drug: Fexofenadine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)
Measured: Before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00 and 12:00 hours after dosing on day 3
Cmax,ss (maximum concentration of dabigatran in plasma at steady state)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
AUC0-∞ (area under the concentration-time curve of fexofenadine in plasma over the time interval from 0 to infinity)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
Cmax (maximum measured concentration of fexofenadine in plasma)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
Secondary outcomes (20)
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: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)
Measured: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state)
Measured: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
CL/Fss (apparent clearance of dabigatran in the plasma at steady state)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cmin,ss (minimum measured concentration of dabigatran in plasma at steady state)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cavg (average concentration of dabigatran at steady state)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
C10,2 (total dabigatran concentration 10 hours after the second dabigatran etexilate administration)
Measured: Day 2, 22 hours after the first dose on day 1
tmin,ss (time from last dosing to the minimum concentration of dabigatran in plasma at steady state over a uniform dosing interval τ)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
MRTpo,ss (mean residence time of dabigatran in the body at steady state after oral administration)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Vz/Fss (apparent volume of distribution of dabigatran during the terminal phase λz at steady state following an extravascular administration)
Measured: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cmax (maximum measured concentration of quinidine in plasma)
Measured: Pre-dose, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 11:00, 13:00, 25:00 and 49 hours after dosing
AUC0-∞ (area under the concentration-time curve of quinidine in plasma over the time interval from 0 to infinity)
Measured: Pre-dose, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 11:00, 13:00, 25:00 and 49 hours after dosing
AUC0-tz (area under the concentration-time curve of fexofenadine in plasma from the time point 0 after the last dose to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
tmax (time from last dosing to the maximum measured concentration of fexofenadine in plasma)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
t½ (terminal half-life of fexofenadine in plasma)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
MRTpo (mean residence time of fexofenadine in the body after p.o. administration)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
CL/F (apparent clearance of fexofenadine in plasma following extravascular administration)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
Vz/F (apparent volume of distribution of fexofenadine during the terminal phase λz following an extravascular dose)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
t½ (terminal half-life of dabigatran in plasma at steady state)
Measured: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 3
Cpre,ss (pre-dose concentration of dabigatran in plasma immediately before administration of the following dose at steady state)
Measured: Before dose on day 3, day 4, and day 5
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 startNov 2007
- Primary completionJan 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
- None (open label)
- Enrolment
- 42 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
- NCT02171546
- Sponsor's protocol ID
- 1160.75
- 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
- A Two-part Study to Determine the Relative Bioavailability of Dabigatran Etexilate 150 mg Bid (Capsules) With and Without 600 mg Quinidine Sulfate Tablets (Part 1) and to Measure the Effect of Quinidine as a Probe Inhibitor of P-glycoprotein on the Absorption of Fexofenadine, a Probe Substrate of P-glycoprotein (Part 2) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two Times Two-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02171546
- Acronym / sponsor ID
- 1160.75
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 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.
Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate,
Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate capsules | Active comparator | Drug: Dabigatran etexilate capsules |
| Dabigatran etexilate capsules and quinidine sulfate tablets | Experimental | Drug: Dabigatran etexilate capsules, Drug: Quinidine sulfate tablets |
| Fexofenadine tablets | Active comparator | Drug: Fexofenadine tablets |
| Fexofenadine and quinidine sulfate tablets | Experimental | Drug: Quinidine sulfate tablets, Drug: Fexofenadine tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 ≤55 years;
- Body Mass Index (BMI) ≥18.5 and BMI <30 kg/m2;
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation;
- If female of child-bearing potential, not be pregnant or breast feeding, nor plan to become pregnant for the duration of the study and for 2 months after receiving the last dose of study drug, and have a negative serum pregnancy test within 14 days of treatment, and prior to dosing;
Key exclusion criteria (23 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 capsules | Drug | Dabigatran etexilate capsules, Dabigatran etexilate capsules and quinidine sulfate tablets |
| Quinidine sulfate tablets | Drug | Dabigatran etexilate capsules and quinidine sulfate tablets, Fexofenadine and quinidine sulfate tablets |
| Fexofenadine tablets | Drug | Fexofenadine and quinidine sulfate tablets, Fexofenadine tablets |
Primary outcome
AUCτ,ss (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)
Time frame: Before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00 and 12:00 hours after dosing on day 3
Cmax,ss (maximum concentration of dabigatran in plasma at steady state)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
AUC0-∞ (area under the concentration-time curve of fexofenadine in plasma over the time interval from 0 to infinity)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
Cmax (maximum measured concentration of fexofenadine in plasma)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
20 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: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)
Time frame: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state)
Time frame: 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3
CL/Fss (apparent clearance of dabigatran in the plasma at steady state)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cmin,ss (minimum measured concentration of dabigatran in plasma at steady state)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cavg (average concentration of dabigatran at steady state)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
C10,2 (total dabigatran concentration 10 hours after the second dabigatran etexilate administration)
Time frame: Day 2, 22 hours after the first dose on day 1
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: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
MRTpo,ss (mean residence time of dabigatran in the body at steady state after oral administration)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Vz/Fss (apparent volume of distribution of dabigatran during the terminal phase λz at steady state following an extravascular administration)
Time frame: Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3
Cmax (maximum measured concentration of quinidine in plasma)
Time frame: Pre-dose, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 11:00, 13:00, 25:00 and 49 hours after dosing
AUC0-∞ (area under the concentration-time curve of quinidine in plasma over the time interval from 0 to infinity)
Time frame: Pre-dose, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 11:00, 13:00, 25:00 and 49 hours after dosing
AUC0-tz (area under the concentration-time curve of fexofenadine in plasma from the time point 0 after the last dose to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
tmax (time from last dosing to the maximum measured concentration of fexofenadine in plasma)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
t½ (terminal half-life of fexofenadine in plasma)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
MRTpo (mean residence time of fexofenadine in the body after p.o. administration)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
CL/F (apparent clearance of fexofenadine in plasma following extravascular administration)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
Vz/F (apparent volume of distribution of fexofenadine during the terminal phase λz following an extravascular dose)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1
t½ (terminal half-life of dabigatran in plasma at steady state)
Time frame: Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 3
Cpre,ss (pre-dose concentration of dabigatran in plasma immediately before administration of the following dose at steady state)
Time frame: Before dose on day 3, day 4, and day 5
Results and safety
The study was stopped early. Results are not available in the source record.
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 capsules, Quinidine sulfate tablets and Fexofenadine tablets 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 6 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: stopped early, 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 was stopped early. Results are not available in the source record.
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 (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval) (time frame: Before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00 and 12:00 hours after dosing on day 3). 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?
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.