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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin; Aspirin, Dipyridamole Drug Combination; Dipyridamole

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