Clinical trial NCT02251184: Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: area under the concentration time curve (AUC0-12)
timeFrame: up to 12 hours
Secondary outcomes:
measure: area under the concentration time curve 0-48 hours (AUC0-48)
timeFrame: up to 48 hours
measure: area under the concentration time curve extrapolated to infinity (AUC0-inf)
timeFrame: up to 3 days
measure: maximum observed plasma concentration (Cmax)
timeFrame: up to 3 days
measure: time to maximum observed plasma concentration (Tmax)
timeFrame: up to 3 days
measure: terminal half life (t1/2)
timeFrame: up to 3 days
measure: number of subjects with adverse events
timeFrame: up to 3 weeks
measure: number of subjects with clinically significant changes in laboratory findings
timeFrame: up to 17 days
Other outcomes:
Locations:
Study officials:
References: