Healthy
Conditions
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 Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VASP-Ser239 / VASP-Ser157-phosphorylation | up to day 10 | induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dipyridamole plasma levels | up to day 10 | by High Performance Liquid Chromatography (HPLC) |
Outcome results
None listed