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CompletedNCT02171611Updated May 23, 2017Results posted

Bioavailability of Different Applications of Dabigatran in Healthy Volunteers

A Phase 1 interventional study of Dabigatran etexilate pellets and Dabigatran etexilate powder in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 ≤50 years
  • BMI ≥18.5 and BMI ≤29.9 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 could reasonably influence the results of the trial (especially unspecific inducing agents like St. John´s wort (Hypericum perforatum) 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 was 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 Torsade de Pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)

  • For female subjects:

    • Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
    • No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were to be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
    • Lactation
  • Intake of medication, which influences the blood clotting, i.e. acetylsalicylic acid, oral vitamin K antagonists etc.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Dabigatran etexilate pellets

    Drug: Dabigatran etexilate pellets

  • Experimental
    Dabigatran etexilate powder

    Drug: Dabigatran etexilate powder

  • Active comparator
    Dabigatran etexilate capsule

    Drug: Dabigatran etexilate capsule

Interventions

  • DrugDabigatran etexilate pellets
  • DrugDabigatran etexilate powder
  • DrugDabigatran etexilate capsule
06

What researchers measure

Primary outcomes

  1. AUC0-inf for Total Dabigatran

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  2. AUC0-inf for Free Dabigatran

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  3. Cmax for Total Dabigatran

    Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  4. Cmax for Free Dabigatran

    Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Secondary outcomes

  1. AUC0-tz for Total Dabigatran

    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) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  2. AUC0-tz for Free Dabigatran

    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) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  3. Tmax for Total Dabigatran

    Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  4. Tmax for Free Dabigatran

    Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  5. λz for Total Dabigatran

    Terminal rate constant in plasma (λz) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  6. λz for Free Dabigatran

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  7. t1/2 for Total Dabigatran

    Terminal half-life of the analyte in plasma (t1/2) for total dabigatran

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  8. t1/2 for Free Dabigatran

    Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  9. MRTpo for Total Dabigatran

    Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  10. MRTpo for Free Dabigatran

    Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  11. CL/F for Total Dabigatran

    Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  12. CL/F for Free Dabigatran

    Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  13. Vz/F for Total Dabigatran

    Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  14. Vz/F for Free Dabigatran

    Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.

    Time frame: -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

  15. Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.

    Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events. There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests.

    Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

  16. Percentage of Participants With Drug-related Adverse Events

    Percentage of participants with investigator defined drug-releated Adverse events.

    Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

  17. Assessment of Tolerability by Investigator.

    Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.

    Time frame: From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.

07

Results

Posted Apr 25, 2017

Participant flow

Participant flow — Overall Study
MilestoneA/B/CA/C/BB/A/CB/C/AC/A/BC/B/A
Started555555
Completed555555
Not completed000000

Outcome measures

PrimaryAUC0-inf for Total Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng(nanogram)*h(hour)/mL(milliliter)
AUC0-inf for Total Dabigatran
ng(nanogram)*h(hour)/mL(milliliter)Dabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
AUC0-inf for Total Dabigatran599 ± 93.31050 ± 33.8928 ± 32.8
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means: 175.14 · 90% CI 141.904 to 216.149Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means: 154.84 · 90% CI 127.425 to 188.161Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
PrimaryAUC0-inf for Free Dabigatran

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng*h/mL
AUC0-inf for Free Dabigatran
ng*h/mLDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
AUC0-inf for Free Dabigatran464 ± 97.3815 ± 40734 ± 38.2
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means in %: 175.4 · 90% CI 141.924 to 216.772Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means in %: 158.12 · 90% CI 130.052 to 192.255Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
PrimaryCmax for Total Dabigatran

Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng/mL
Cmax for Total Dabigatran
ng/mLDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Cmax for Total Dabigatran74.6 ± 110139 ± 37.8124 ± 37
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means: 186.94 · 90% CI 147.659 to 236.665Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means in %: 166.59 · 90% CI 133.221 to 208.326Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
PrimaryCmax for Free Dabigatran

Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng/mL
Cmax for Free Dabigatran
ng/mLDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Cmax for Free Dabigatran61.5 ± 110112 ± 40.4103 ± 40.7
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means in %: 181.6 · 90% CI 145.428 to 226.776Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means in %: 166.83 · 90% CI 134.25 to 207.328Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).
SecondaryAUC0-tz for Total Dabigatran

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) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng*h/mL
AUC0-tz for Total Dabigatran
ng*h/mLDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
AUC0-tz for Total Dabigatran565 ± 1061030 ± 34.2908 ± 33.5
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means in %: 182.17 · 90% CI 144.727 to 229.297Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means in %: 160.74 · 90% CI 129.633 to 199.306Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
SecondaryAUC0-tz for Free Dabigatran

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) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · ng*h/mL
AUC0-tz for Free Dabigatran
ng*h/mLDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
AUC0-tz for Free Dabigatran436 ± 110794 ± 41.3715 ± 39.5
Statistical analysis
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Pellets: Test 1 (B) · Ratio of adjusted geometric means in %: 182.25 · 90% CI 144.993 to 229.075Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
  • Dabigatran Etexilate 150 mg Capsule: Reference (A) vs Dabigatran Etexilate 150 mg Powder: Test 2 (C) · Ratio of adjusted geometric means in %: 164.01 · 90% CI 132.421 to 203.14Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.
SecondaryTmax for Total Dabigatran

Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Median · hour
Tmax for Total Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Tmax for Total Dabigatran2.0 (1.5 to 6.0)1.5 (1.0 to 3.0)1.5 (1.0 to 2.5)
SecondaryTmax for Free Dabigatran

Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Median · hour
Tmax for Free Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Tmax for Free Dabigatran2.0 (1.5 to 6.0)1.51 (1.0 to 3.0)1.5 (1.0 to 2.0)
Secondaryλz for Total Dabigatran

Terminal rate constant in plasma (λz) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · 1/hour
λz for Total Dabigatran
1/hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
λz for Total Dabigatran0.079 ± 13.50.074 ± 14.50.0756 ± 16.4
Secondaryλz for Free Dabigatran
Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · 1/hour
λz for Free Dabigatran
1/hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
λz for Free Dabigatran0.091 ± 160.0811 ± 18.60.0893 ± 15.7
Secondaryt1/2 for Total Dabigatran

Terminal half-life of the analyte in plasma (t1/2) for total dabigatran

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · hour
t1/2 for Total Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
t1/2 for Total Dabigatran8.77 ± 13.59.37 ± 14.59.16 ± 16.4
Secondaryt1/2 for Free Dabigatran

Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · hour
t1/2 for Free Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
t1/2 for Free Dabigatran7.62 ± 168.54 ± 18.67.76 ± 15.7
SecondaryMRTpo for Total Dabigatran

Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · hour
MRTpo for Total Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
MRTpo for Total Dabigatran10.8 ± 1210.1 ± 11.410 ± 12.2
SecondaryMRTpo for Free Dabigatran

Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · hour
MRTpo for Free Dabigatran
hourDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
MRTpo for Free Dabigatran9.9 ± 14.09.58 ± 14.19.15 ± 12.2
SecondaryCL/F for Total Dabigatran

Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · mL (milliliter)/min (minute)
CL/F for Total Dabigatran
mL (milliliter)/min (minute)Dabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
CL/F for Total Dabigatran3130 ± 93.31790 ± 33.82020 ± 32.8
SecondaryCL/F for Free Dabigatran

Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · mL (milliliter)/min (minute)
CL/F for Free Dabigatran
mL (milliliter)/min (minute)Dabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
CL/F for Free Dabigatran4040 ± 97.32310 ± 402560 ± 38.2
SecondaryVz/F for Total Dabigatran

Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · Liter
Vz/F for Total Dabigatran
LiterDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Vz/F for Total Dabigatran2380 ± 92.81450 ± 351610 ± 35.9
SecondaryVz/F for Free Dabigatran

Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.

Time frame:
-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.
Reported as:
Geometric mean · Liter
Vz/F for Free Dabigatran
LiterDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Vz/F for Free Dabigatran2670 ± 911700 ± 41.41720 ± 37.6
SecondaryPercentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.

Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events. There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests.

Time frame:
From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Reported as:
Number · Percentage of participants
Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.
Percentage of participantsDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.0.00.00.0
SecondaryPercentage of Participants With Drug-related Adverse Events

Percentage of participants with investigator defined drug-releated Adverse events.

Time frame:
From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Reported as:
Number · Percentage of participants
Percentage of Participants With Drug-related Adverse Events
Percentage of participantsDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Percentage of Participants With Drug-related Adverse Events6.723.326.7
SecondaryAssessment of Tolerability by Investigator.

Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.

Time frame:
From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
Reported as:
Number · Percentage of Participants
Assessment of Tolerability by Investigator.
Percentage of ParticipantsDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
Good100.0100.0100.0
Satisfactory0.00.00.0
Not satisfactory0.00.00.0
Bad0.00.00.0
Not assessable0.00.00.0

Adverse events

Collected over From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dabigatran Etexilate 150 mg Capsule: Reference (A)—0/30 (0%)2/30 (6.7%)
Dabigatran Etexilate 150 mg Pellets: Test 1 (B)—0/30 (0%)7/30 (23.3%)
Dabigatran Etexilate 150 mg Powder: Test 2 (C)—0/30 (0%)8/30 (26.7%)
Most frequent other events
Most frequent other events
EventDabigatran Etexilate 150 mg Capsule: Reference (A)Dabigatran Etexilate 150 mg Pellets: Test 1 (B)Dabigatran Etexilate 150 mg Powder: Test 2 (C)
HeadacheNervous system disorders2/305/308/30
Abdominal pain upperGastrointestinal disorders0/302/300/30

Baseline characteristics

Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment. This set was used for safety analysis.

Age, Continuous
Age, Continuous(Years)Overall
Mean39.8 ± 8.2
Sex: Female, Male
Sex: Female, Male(Participants)Overall
Female10
Male20
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02171611
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 24, 2014
Start date
Mar 2009
Primary completion
May 2009
Results posted
Apr 25, 2017
Last update
May 23, 2017
View the source record on ClinicalTrials.gov ↗

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