Status:
COMPLETED
Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
Brief Summary
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02251184
Start Date
October 1 2000
Last Update
September 29 2014
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