Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects
Condition: Healthy
Intervention: dabigatran etexilate
Intervention description: single dose
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to establish the bioequivalence of tablet formulation
      of dabigatran etexilate compared to commercial capsule formulation following oral
      administration under fasted condition.

      The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters between the treatments.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will only be included into the trial, if they meet the following criteria:

          -  Healthy male subjects according to the investigator's assessment, based on a complete
             medical history including a physical examination, vital signs (blood pressure (BP),
             pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

          -  Age ≥20 and ≤40 years old at informed consent

          -  BMI ≥18 and ≤25 kg/m2 at screening

          -  Signed and dated written informed consent prior to admission to the trial in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion Criteria:

        Subjects will not be allowed to participate if any of the following general criteria apply:

          -  Any finding in the medical examination (including blood pressure (BP), pulse rate
             (PR)or electrocardiogram (ECG)) is deviating from normal and judged as clinically
             relevant by the investigator

          -  Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic
             blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of
             45 to 90 bpm at screening. Based on the clinical judge by the investigator, repeated
             measurements are allowed.

          -  Any laboratory value outside the reference range before randomisation that the
             investigator considers to be of clinical relevance

          -  Any evidence of a concomitant disease considered as clinically relevant by the
             investigator

          -  Any relevant bleeding history considered by the investigator

          -  Any history or evidence of blood dyscrasia, haemorrhagic diathesis, severe
             thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with
             active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary
             tract or any disease or condition with haemorrhagic tendencies

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia
             repair)

          -  Planned surgeries within four weeks following the end-of trial examination

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts

          -  Chronic or relevant acute infections

          -  History of relevant allergy or hypersensitivity (including allergy to the trial
             medication or its excipients)

          -  Use of drugs within 30 days prior to administration of trial medication if that might
             reasonably influence the results of the trial (incl.Qc/QTc interval prolongation)

          -  Participation in another trial where an investigational drug has been administered
             within 60 days prior to planned administration of trial medication, or current
             participation in another trial involving administration of investigational drug

          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

          -  Inability to refrain from smoking in-house confinement at the trial site

          -  Alcohol abuse (consumption of more than 30 g per day: e.g., 750 mL of beer, 1.5 gous
             [equivalent to 270 mL] of Sake)

          -  Drug abuse or positive drug screening

          -  Blood donation of more than 100 mL within 30 days prior to administration of trial
             medication or intended donation during the trial

          -  Intention to perform excessive physical activities within one week prior to
             administration of trial medication or during the trial

          -  Inability to comply with dietary regimen of trial site

          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
             because considered not able to understand and comply with trial requirements, or has a
             condition that would not allow safe participation in the trial