Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

Launched by BOEHRINGER INGELHEIM · Jul 2, 2014

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male subjects as determined by results of screening
• • 2. Signed written informed consent in accordance with GCP and local legislation
• • 3. Age ≥21 and ≤55 years
• • 4. Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
• Exclusion Criteria:
• • 1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• • 2. History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• • 3. History of relevant orthostatic hypotension, fainting spells and blackouts
• • 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • 5. Chronic or relevant acute infections
• • 6. History of allergy/hypersensitivity (including drug allergy or its excipients) which is deemed relevant to the trial as judged by the investigator
• • 7. History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
• • 8. Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• • 9. Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial
• • 10. Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• • 11. Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• • 12. Alcohol abuse (\> 60 g/day)
• • 13. Drug abuse
• • 14. Blood donation (more than 150 mL within 4 weeks prior to administration or during the trial)
• • 15. Excessive physical activities within 5 days prior to administration or during the trial
• • 16. Any laboratory value outside the reference range that is of clinical relevance
• • 17. Female gender
• • 18. Male subjects refuse to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide