Bioequivalence of Two Different Capsule Types of Dabigatran
Condition: Healthy
Intervention: Dabigatran etexilate; Dabigatran etexilate
Intervention description: 150 mg Capsugel (T); 150 mg Qualicaps (R)
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of
      dabigatran etexilate made from two different drug product batches.

      The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved
      capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using
      a new capsule shell (Capsugel). The test batch is the drug product intended for future
      commercial use.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males and females according to the following criteria: Based upon a complete
             medical history, including the physical examination, vital signs (blood pressure (BP),
             pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

          2. Age =21 and = 55 years

          3. Body Mass Index (BMI) =18.5 and BMI = 29.9 kg/m^2

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and the local legislation

        Exclusion criteria:

          1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular,
             metabolic, immunological or hormonal disorders

          2. Clinically relevant surgery of gastrointestinal tract or evidence of significant
             gastrointestinal motility problems that could affect absorption of the drug

          3. Diseases of the central nervous system (included but not limited to any kind of
             seizures, stroke or psychiatric disorders) within the past 6 month

          4. Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe
             thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with
             active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary
             tract or any disease or condition with hemorrhagic tendencies

          5. History of relevant orthostatic hypotension, fainting spells or blackouts

          6. Chronic or relevant acute infections

          7. History of allergy/hypersensitivity (including drug allergy in particular to study
             drug or its excipients) which is deemed relevant to the trial as judged by the
             investigator

          8. Use of drugs which might reasonably influence the results of the trial based on the
             knowledge at the time of protocol preparation within 10 days prior to administration
             or during the trial

          9. Alcohol abuse (more than 20 g/day)

         10. Drug abuse

         11. Any laboratory value outside the reference range that is of clinical relevance
             (especially hemoglobin, thrombocytes, prothrombin time (PT) and Activated Partial
             Thromboplastin Time (Measure of the clotting time) (aPTT) or positive drug or virus
             screening

         12. Planned surgeries within four weeks following the end-of study examination

         13. Recent or contemplated diagnostic or therapeutic procedures with potential for
             uncontrollable bleeding within 14 days before or after end-of study examination