Healthy
Conditions
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the concentration time curve (AUC0-12) | up to 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| area under the concentration time curve extrapolated to infinity (AUC0-inf) | up to 3 days |
| maximum observed plasma concentration (Cmax) | up to 3 days |
| time to maximum observed plasma concentration (Tmax) | up to 3 days |
| area under the concentration time curve 0-48 hours (AUC0-48) | up to 48 hours |
| number of subjects with adverse events | up to 3 weeks |
| number of subjects with clinically significant changes in laboratory findings | up to 17 days |
| terminal half life (t1/2) | up to 3 days |
Outcome results
None listed