Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers

Launched by BOEHRINGER INGELHEIM · Aug 26, 2014

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy females/males
• • Age range from 18 to 60
• • Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation
• Exclusion Criteria:
• • Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• • Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• • Known 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
• • Drug intake with long half-life (\> 24 hours), \< 1 month prior to administration or during the trial
• • Volunteers received any other drugs which might influence the results of the trial, \< 10 days prior to administration or during the trial
• • Participation in another study with an investigational drug, \< 1 month prior to administration or during the trial
• • Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day
• • Drinking more than 60 g of alcohol per day
• • Unable to refrain from excessive consumption of methylxanthine containing drinks or food
• • Drug addiction
• • Blood donation (\> 400 ml), \< 4 weeks prior to administration or during the trial
• • Participation in excessive physical activities, \< 5 days prior to administration or during the trial
• For female volunteers:
• • Pregnancy
• • Positive pregnancy test
• • No adequate contraception (acceptable: oral contraceptives, condoms, etc.)
• • Lactation period