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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Acetylsalicylic acid; Drug: Aggrenox; Drug: Persantin Retard

Study type: Interventional

Funder types: Industry

Identifiers

NCT02226926

9.142

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Aggrenox

Experimental group

Description:

Dipyridamole extended release / Acetylsalicylic acid

Treatment:

Drug: Aggrenox

Persantin Retard

Active Comparator group

Description:

Dipyridamole extended release

Treatment:

Drug: Persantin Retard

Acetylsalicylic acid

Active Comparator group

Treatment:

Drug: Acetylsalicylic acid