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: Drug: Dipyridamole; Drug: Aggrenox; Drug: Lansoprazole; Drug: Aspirin

• 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

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2000-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Last Update Submitted: 2014-09-25
• Study First Posted: 2014-09-29
• Last Update Posted: 2014-09-29

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