Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects
Condition: Healthy
Intervention: Dabigatran etexilate tablet E1; Dabigatran etexilate tablet D1; Dabigatran etexilate tablet C1; Dabigatran etexilate tablet B1; Dabigatran etexilate tablet A1; 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: 35.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the relative bioavailability of five
      different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1,
      Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule
      formulation of Dabigatran Etexilate.

      The secondary objective is to evaluate and compare several pharmacokinetic parameters between
      the treatments.
    

Eligibility criteria:

        Inclusion 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 <=35 years old

          -  Body mass index (BMI) >=18.0 and <=25.0 kg/m2

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, Pulse Rate, or ECG) deviating
             from normal and judged as clinically relevant by the investigator at screening

          -  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

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any relevant bleeding history considered by the investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the trial
             medication (except appendectomy and simple hernia repair)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  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

          -  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)

          -  Any evidence of a concomitant disease considered as clinically relevant by the
             investigator

          -  Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than
             10 half-lives of the respective drug prior to administration of trial medication

          -  Within 10 days prior to administration of trial medication, use of drugs that might
             reasonably influence the results of the trial

          -  Intake of medication, which influences the blood clotting, e.g., acetylsalicylic acid,
             coumarin etc. within 10 days prior to trial medication

          -  Participation in another trial where an investigational drug has been administered
             within 4 months or 5 half-lives (whichever is greater) prior to planned administration
             of trial medication

          -  Planned surgeries within four weeks following the end-of study examination

          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

          -  Inability to refrain from smoking during 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 assessed as unsuitable for inclusion by the investigator because of, for
             instance, being considered not able to understand and comply with study requirements,
             or having a condition that would not allow safe participation in the study