HealthyPhase 1NCT02171026
Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran etexilate and Amiodarone in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of the bioavailability, safety and tolerability of dabigatran with and without concomitant administration of amiodarone and the bioavailability of amiodarone and desethylamiodarone after administration of a single dose of amiodarone with and without dabigatran 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 Amiodarone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jun 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 (BP, pulse rate (PR)), 12-lead ECG, clinical laboratory tests
- Aged >=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 according to GCP and 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 or acute blood coagulation defect
- Diseases of the central nervous system, such as epilepsy; psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 18Show fewer
- History of allergy/hypersensitivity, including drug allergy, which was deemed relevant to the study 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 study
- Use of drugs, which might have reasonably influenced the results of the study based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the study
- Participation in another study with an investigational drug within two months prior to administration or during the study
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation; more than 100 mL within four weeks prior to administration or during the study
- Excessive physical activities; within one week prior to administration or during the study
- Any laboratory value outside the reference range that was of clinical relevance
- Inability to comply with dietary regimen of study centre
- Females of child bearing potential who were pregnant, breast feeding or who were either not surgically sterile or were sexually active and not using an acceptable, i.e. highly effective with a Pearl index >1%, 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 18.) Male subjects had to 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. Acceptable methods of contraception comprised barrier contraception and a medically accepted contraceptive method for the female partner (intrauterine device with spermicide, hormonal contraceptive since at least two month).
- 19.) Abnormal thyroid stimulating hormone (TSH) at screening
About this study
Official title: Relative Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of 150 mg Dabigatran Etexilate b.i.d. With or Without 600 mg Amiodarone as Single Dose in Healthy Male and Female Volunteers (an Open-Label, Multiple-Dose, Group-Comparison Study)
Investigation of the bioavailability, safety and tolerability of dabigatran with and without concomitant administration of amiodarone and the bioavailability of amiodarone and desethylamiodarone after administration of a single dose of amiodarone with and without dabigatran
- Conditions
- Healthy
- Being tested
- Dabigatran etexilate, Amiodarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
AmiodaroneDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate + Amiodarone | Experimental | Not described Receives: Drug: Dabigatran etexilate; Drug: Amiodarone |
| Amiodarone | Active comparator | Not described Receives: Drug: Amiodarone |
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 the analyte in plasma over one steady state dosing interval)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h post-dose on day 3, pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose on day 4
Cmax,ss (maximum concentration of the analyte in plasma at steady state)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h post-dose on day 3, pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose on day 4
AUC0-infinity (area under the concentration time curve of the analyte in plasma extrapolated to infinity)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Cmax (maximum concentration of the analyte in plasma)
Measured: pre-dose on day 1 and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Changes in aPTT (activated partial thromboplastin time)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Changes in ECT (ecarin clotting time)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
AUERτ,ss (area under the effect ratio-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
ERmax,ss (maximum effect ratio in plasma at steady state)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Secondary outcomes (27)
AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tz,ss (time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state on Day 4)
Measured: pre-dose Day 4 and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
CL/Fss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tmin,ss (time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Cpre,ss (pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
MRTp.o.,ss (mean residence time of the analyte in the body at steady state after oral administration)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Vz/Fss (apparent volume of distribution of the analyte during the terminal phase λz at steady state following an extravascular administration)
Measured: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Aeτ,ss (amount of the analyte eliminated in urine at steady state over an uniform dosing interval τ)
Measured: pre-dose, 0-12 h and 12-24 h post-dose on days 3 and 4
feτ,ss (fraction of the analyte eliminated in urine at steady state over a uniform dosing interval τ)
Measured: pre-dose, 0-12 h and 12-24 h post-dose on days 3 and 4
AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval 0 to the last quantifiable analyte plasma concentration after single dose administration)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
tz (time of last measurable concentration of the analyte in plasma following a single dose)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
%AUCtz-infinity (percentage of the AUC0-infinity of the analyte obtained by extrapolation)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
tmax (time from dosing to the maximum concentration of the analyte in plasma following a single dose)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
λz (terminal rate constant of the analyte in plasma after a single dose)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
t1/2 (terminal half-life of the analyte in plasma after a single dose)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
MRTp.o. (mean residence time of the analyte in the body after single dose p.o. administration
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
CL/F (apparent clearance of the analyte in the plasma after extravascular single dose administration)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following extravascular dose)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Changes in physical examination
Measured: up to 8 days following drug administration
Changes in vital signs (BP, PR)
Measured: up to 8 days following drug administration
Changes in 12-lead electrocardiogram (ECG)
Measured: up to 8 days following drug administration
Changes in clinical laboratory tests
Measured: up to 8 days following drug administration
Occurrence of adverse events
Measured: up to 8 days following drug administration
Assessment of tolerability by investigator
Measured: up to 8 days following drug administration
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 completionJun 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
- Parallel groups
- 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
- NCT02171026
- Sponsor's protocol ID
- 1160.57
- 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
- Relative Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of 150 mg Dabigatran Etexilate b.i.d. With or Without 600 mg Amiodarone as Single Dose in Healthy Male and Female Volunteers (an Open-Label, Multiple-Dose, Group-Comparison Study)
- ClinicalTrials.gov ID
- NCT02171026
- Acronym / sponsor ID
- 1160.57
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 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.
Investigation of the bioavailability, safety and tolerability of dabigatran with and without concomitant administration of amiodarone and the bioavailability of amiodarone and desethylamiodarone after administration of a single dose of amiodarone with and without dabigatran
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate + Amiodarone | Experimental | Drug: Dabigatran etexilate, Drug: Amiodarone |
| Amiodarone | Active comparator | Drug: Amiodarone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Based upon a complete medical history, including the physical examination, vital signs (BP, pulse rate (PR)), 12-lead ECG, clinical laboratory tests
- Aged >=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 according to GCP and local legislation
Key exclusion criteria (18 listed)
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect
- Diseases of the central nervous system, such as epilepsy; 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 + Amiodarone |
| Amiodarone | Drug | Amiodarone, Dabigatran etexilate + Amiodarone |
Primary outcome
AUCτ,ss (area under the concentration time curve of the analyte in plasma over one steady state dosing interval)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h post-dose on day 3, pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose on day 4
Cmax,ss (maximum concentration of the analyte in plasma at steady state)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h post-dose on day 3, pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose on day 4
AUC0-infinity (area under the concentration time curve of the analyte in plasma extrapolated to infinity)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Cmax (maximum concentration of the analyte in plasma)
Time frame: pre-dose on day 1 and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Changes in aPTT (activated partial thromboplastin time)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Changes in ECT (ecarin clotting time)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
AUERτ,ss (area under the effect ratio-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
ERmax,ss (maximum effect ratio in plasma at steady state)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
27 secondary outcomes
AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tz,ss (time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state on Day 4)
Time frame: pre-dose Day 4 and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
CL/Fss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
tmin,ss (time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Cpre,ss (pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
MRTp.o.,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Vz/Fss (apparent volume of distribution of the analyte during the terminal phase λz at steady state following an extravascular administration)
Time frame: pre-dose on Day 1, 2, 3, and 4; on day 3 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h post-dose; on day 4 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 h post-dose
Aeτ,ss (amount of the analyte eliminated in urine at steady state over an uniform dosing interval τ)
Time frame: pre-dose, 0-12 h and 12-24 h post-dose on days 3 and 4
feτ,ss (fraction of the analyte eliminated in urine at steady state over a uniform dosing interval τ)
Time frame: pre-dose, 0-12 h and 12-24 h post-dose on days 3 and 4
AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval 0 to the last quantifiable analyte plasma concentration after single dose administration)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
tz (time of last measurable concentration of the analyte in plasma following a single dose)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
%AUCtz-infinity (percentage of the AUC0-infinity of the analyte obtained by extrapolation)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
tmax (time from dosing to the maximum concentration of the analyte in plasma following a single dose)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
λz (terminal rate constant of the analyte in plasma after a single dose)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
t1/2 (terminal half-life of the analyte in plasma after a single dose)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
MRTp.o. (mean residence time of the analyte in the body after single dose p.o. administration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
CL/F (apparent clearance of the analyte in the plasma after extravascular single dose administration)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following extravascular dose)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose
Changes in physical examination
Time frame: up to 8 days following drug administration
Changes in vital signs (BP, PR)
Time frame: up to 8 days following drug administration
Changes in 12-lead electrocardiogram (ECG)
Time frame: up to 8 days following drug administration
Changes in clinical laboratory tests
Time frame: up to 8 days following drug administration
Occurrence of adverse events
Time frame: up to 8 days following drug administration
Assessment of tolerability by investigator
Time frame: up to 8 days following drug administration
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 etexilate and Amiodarone 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 18 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?
AUCτ,ss (area under the concentration time curve of the analyte in plasma over one steady state dosing interval) (time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 h post-dose on day 3, pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 120 h post-dose on day 4). The study lists 8 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.