Bioavailability of Dabigatran With or Without Clarithromycin in Healthy Volunteers

Launched by BOEHRINGER INGELHEIM · Jun 20, 2014

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Healthy males and females ≥18 and ≤50 years of age, based on a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests.
• • Body mass index (BMI) ranging from 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:
• • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• • Any evidence of a clinically relevant concomitant disease
• • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• • Surgery of the gastrointestinal tract (except appendectomy)
• • 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• • Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• • Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• • Participation in another trial with an investigational drug within two months prior to administration or during the trial
• • Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• • Alcohol abuse (more than 60 g/day)
• • Drug abuse
• • Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
• • Excessive physical activities (within one week prior to administration or during the trial)
• • Any laboratory value outside the reference range that is of clinical relevance
• • Inability to comply with dietary regimen of trial site
• • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
• • A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
• * In addition, the following exclusion criteria applied to females:
• • Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
• • No adequate contraception during the study and until 1 month of study completion, (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 \[including hysterectomy\] were considered adequate contraception. Females whose partner was not vasectomised, were not sexually abstinent, or surgically sterile were asked to use barrier contraception methods (e.g. condom, diaphragm with spermicide)
• • Lactation period
• • Intake of medication, which influenced blood coagulation, including acetylsalicylic acid and oral vitamin K antagonists, among others