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

Safety, Tolerability and Pharmacokinetics Study After Single and Multiple Oral Doses of Dabigatran Etexilate Capsule (110mg,150 mg b.i.d., 7 Days) in Healthy Chinese Subjects (Open Label Study)

The objective of the current study is to investigate safety, tolerability and, pharmacokinetics of dabigatran etexilate following oral administration of single and multiple oral doses (110mg, 150 mg b.i.d., 7 days) 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.