Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
Condition: Healthy
Intervention: Dabigatran etexilate; Dabigatran etexilate; Dabigatran etexilate
Intervention description: Pellets (multiple dose of dabigatran); Granules resolved in reconstitution solution (multiple dose of dabigatran); Hard capsule (multiple dose of dabigatran)
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

Eligibility 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)