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Trial record 18 of 333 for:    DABIGATRAN

Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02044367
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : April 27, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran etexilate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, Randomised, Multiple-dose, Three Way Crossover Study)
Study Start Date : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test 1 (Treatment A)
multiple dose of dabigatran
Drug: Dabigatran etexilate
Pellets (multiple dose of dabigatran)

Experimental: Test 2 (Treatment B)
multiple dose of dabigatran
Drug: Dabigatran etexilate
Granules resolved in reconstitution solution (multiple dose of dabigatran)

Experimental: Reference
multiple dose of dabigatran
Drug: Dabigatran etexilate
Hard capsule (multiple dose of dabigatran)




Primary Outcome Measures :
  1. Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran. [ Time Frame: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration ]
    Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.

  2. Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran. [ Time Frame: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration ]
    Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.


Secondary Outcome Measures :
  1. Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran. [ Time Frame: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration ]
    Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.

  2. Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran. [ Time Frame: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration ]
    Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.

  3. Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question. [ Time Frame: once on day 3 (48 hours after first dose) ]
    Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.

  4. Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question. [ Time Frame: once on day 3 (48 hours after first dose) ]
    Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
  2. Age 18 to 55 years (incl.)
  3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

  1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
  2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease judged clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
  7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
  8. Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:

    • Hemorrhagic disorders or bleeding diathesis
    • Occult blood in faeces or haematuria
    • Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
    • History of arteriovenous malformation or aneurysm
    • History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
    • History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
    • Anemia at screening
    • Thrombocytopenia (platelet count less than 100/nL)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044367


Locations
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Germany
1160.194.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02044367     History of Changes
Other Study ID Numbers: 1160.194
2013-002498-23 ( EudraCT Number: EudraCT )
First Posted: January 24, 2014    Key Record Dates
Results First Posted: April 27, 2015
Last Update Posted: May 20, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants