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Trial record 18 of 335 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

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Results First Submitted Date  ICMJE April 10, 2015
Results First Posted Date  ICMJE April 27, 2015
Last Update Posted Date May 20, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • 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: up to 60 hours ]
  • Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran. [ Time Frame: up to 60 hours ]
Change History Complete list of historical versions of study NCT02044367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Acceptability rating for pellets (on food) and oral solution will be assessed by asking the subjects 2 multiple choice verbal questions. [ Time Frame: once on day 3 (48 hours after first dose) ]
  • 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: up to 60 hours ]
  • Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran. [ Time Frame: up to 60 hours ]
  • Palatability rating for pellets (on food) and oral solution will be assessed by asking the subjects 2 multiple choice verbal questions. [ Time Frame: once on day 3 (48 hours after first dose) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dabigatran etexilate
    Pellets (multiple dose of dabigatran)
  • Drug: Dabigatran etexilate
    Granules resolved in reconstitution solution (multiple dose of dabigatran)
  • Drug: Dabigatran etexilate
    Hard capsule (multiple dose of dabigatran)
Study Arms  ICMJE
  • Experimental: Test 1 (Treatment A)
    multiple dose of dabigatran
    Intervention: Drug: Dabigatran etexilate
  • Experimental: Test 2 (Treatment B)
    multiple dose of dabigatran
    Intervention: Drug: Dabigatran etexilate
  • Experimental: Reference
    multiple dose of dabigatran
    Intervention: Drug: Dabigatran etexilate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2014)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02044367
Other Study ID Numbers  ICMJE 1160.194
2013-002498-23 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP