Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole
administered as the immediate release formulation plus aspirin, under conditions of reduced
stomach acidity.
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
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