Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers

Inclusion criteria

• Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
• Age ≥18 to ≤55 years
• Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Intake of any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 4 weeks prior to administration or during the trial
• Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)
• Drug abuse
• Intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's wort within 5 days of first dosing
• Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial
• Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)
• Excessive physical activities (within 1 week prior to trial drug administration or during the trial)
• Any laboratory value outside the reference range that was of clinical relevance
• Inability to comply with dietary regimen of study centre
• Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
• Inability to refrain from smoking on trial days

For female subjects:

• Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month after study completion
• No adequate contraception during the study and within 1 month after study completion such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile, were asked to additionally use a barrier contraception method (e.g. condom, diaphragm with spermicide)
• Lactation period