Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects

Launched by BOEHRINGER INGELHEIM · Oct 23, 2014

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy male subjects as determined by results of screening
• • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• • Age \>=50 years
• • BMI \>=18.5 and \<=29.9 kg/m2
• • Able to communicate well with the investigator and to comply with study requirements
• • Laboratory values within a clinically defined reference range
• Exclusion Criteria:
• • Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
• • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
• • Surgery of gastrointestinal tract (except appendectomy)
• • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • History of orthostatic hypotension, fainting spells or blackouts
• • Chronic or relevant acute infections
• • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• • Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
• • Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
• • Participation in another trial with an investigational drug (\< 3 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
• • Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
• • Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• • Alcohol abuse (\> 60 g/day)
• • Drug abuse
• • Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
• • Excessive physical activities (\< 5 days prior to administration or during the trial)
• • Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms or QRS interval \> 110 ms
• • History of any familial bleeding disorder
• • Inability to comply with dietary regimen of study centre
• • Inability to comply with investigator's instructions