Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH
Phase 4
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02251184
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aggrenox Lansoprazole extended release dipyridamole+aspirin Lansoprazole immediate release dipyridamole+aspirin Dipyridamole immediate release dipyridamole+aspirin Aspirin immediate release Aggrenox Aggrenox extended release
- Primary Outcome Measures
Name Time Method area under the concentration time curve (AUC0-12) up to 12 hours
- Secondary Outcome Measures
Name Time Method maximum observed plasma concentration (Cmax) up to 3 days terminal half life (t1/2) up to 3 days area under the concentration time curve 0-48 hours (AUC0-48) up to 48 hours area under the concentration time curve extrapolated to infinity (AUC0-inf) up to 3 days number of subjects with clinically significant changes in laboratory findings up to 17 days time to maximum observed plasma concentration (Tmax) up to 3 days number of subjects with adverse events up to 3 weeks