Bioavailability of Different Applications of Dabigatran in Healthy Volunteers
Condition: Healthy
Intervention: Dabigatran etexilate pellets; Dabigatran etexilate powder; Dabigatran etexilate capsule
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

Eligibility criteria:

        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:

          -  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.