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

NCT ID: NCT02251184

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aggrenox

extended release

Group Type: EXPERIMENTAL

Aggrenox

Intervention Type: DRUG

Lansoprazole

Intervention Type: DRUG

dipyridamole+aspirin

immediate release

Group Type: ACTIVE_COMPARATOR

Dipyridamole

Intervention Type: DRUG

Aspirin

Intervention Type: DRUG

Lansoprazole

Intervention Type: DRUG

Interventions

Aggrenox

Intervention Type: DRUG

Dipyridamole

Intervention Type: DRUG

Aspirin

Intervention Type: DRUG

Lansoprazole

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9.146

Identifier Type: -

Identifier Source: org_study_id