Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects

Inclusion criteria

• Japanese or Caucasian healthy male subjects according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests

• No finding of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan
• Age: ≥20 and ≤45 years
• Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
• Signed and dated written informed consent before admission to the trial site

Exclusion criteria

• Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
• Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
• History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
• Chronic or relevant acute infections
• History of

• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic diseases
• cerebral bleeding (e.g. after a car accident)
• concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
• Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
• Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 days prior to administration up to end-of-study examination
• Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination
• Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial)
• Alcohol abuse (more than 60 g/day; confirmed by interview)
• Drug abuse (confirmed by interview)
• Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination)
• Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination)
• Any laboratory value outside the reference range that is of clinical relevance
• Known hypersensitivity to the investigational drug or its excipients
• Subject who was judged ineligible by the investigator or the sub-investigator
• History of any familial bleeding disorder
• Thrombocytes <15 x 10**4 /microL