Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

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.

Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lansoprazole; Drug: Aspirin; Drug: Dipyridamole; Drug: Aggrenox

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aggrenox; extended release	Drug: Lansoprazole; Drug: Aggrenox
Active Comparator: dipyridamole+aspirin; immediate release	Drug: Lansoprazole; Drug: Aspirin; Drug: Dipyridamole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
area under the concentration time curve (AUC0-12)	up to 12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
maximum observed plasma concentration (Cmax)	up to 3 days
time to maximum observed plasma concentration (Tmax)	up to 3 days
terminal half life (t1/2)	up to 3 days
number of subjects with adverse events	up to 3 weeks
number of subjects with clinically significant changes in laboratory findings	up to 17 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): November 1, 2000

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Phosphodiesterase Inhibitors; Aspirin; Dexlansoprazole; Lansoprazole; Dipyridamole; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.146