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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Aggrenox
* Drug: Persantin Retard
* Drug: Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aggrenox<br>Dipyridamole extended release / Acetylsalicylic acid | Drug: Aggrenox<br> <br> |
| Active Comparator: Persantin Retard<br>Dipyridamole extended release | Drug: Persantin Retard<br> <br> |
| Active Comparator: Acetylsalicylic acid<br> | Drug: Acetylsalicylic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VASP-Ser239 / VASP-Ser157-phosphorylation | induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot) | up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dipyridamole plasma levels | by High Performance Liquid Chromatography (HPLC) | up to day 10 |