Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects

Inclusion criteria

• Healthy subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR and body temperature), 12-lead ECG, clinical laboratory tests

• No finding of clinical relevance.
• No evidence of a clinically relevant concomitant disease.
• Age: ≥18 and ≤45 years.
• Body Mass Index (BMI): ≥18 and <25 kg/m2.
• Signed and dated written informed consent prior to admission to the trial in accordance with Chinese GCP.

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 was 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 was shorter, of the respective drug prior to administration or during the trial.
• Use of aspirin (including over-the-counter medications), antiplatelet agents like ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAID), coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 14 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 < 100×109 .
• Pregnant female subjects.