Status:
COMPLETED
Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02226926
Start Date
July 1 2000
Last Update
August 27 2014
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