Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.

Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.

Inclusion Criteria:

• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age 40 - 65 years, inclusive, at time of Visit 1
• Stomach pH > 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA)

Exclusion Criteria:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance
• History of gastro-intestinal ulcer, perforation or bleeding
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders
• Chronic or relevant acute infections. Screening tests will be performed for HIV, hepatitis B, and hepatitis C
• History of hypersensitivity to Aggrenox or any of the components or excipients
• Intake of drugs with a long dominant half-life (>24 hours) 1 month or less prior to Visit 1
• Use of any drugs which might influence the results of the trial ten days or less prior to Visit 1
• Participation in another trial with an investigational drug 1 month or less prior to Visit 1
• Known alcohol abuse
• Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)
• Blood donation 1 month or less prior to Visit 1
• Excessive physical activities five days or less prior to Visit 1
• History of hemorrhagic diathesis
• History of bronchial asthma
• Any laboratory value outside the reference range, considered by the investigator to be of clinical relevance

For female subjects:

• Nursing
• Pregnancy
• Positive pregnancy test
• No adequate contraception (adequate contraception includes sterilization, intrauterine device, or oral contraceptives)
• Inability to maintain adequate contraception during the whole study period