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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Aspirin; Aspirin, Dipyridamole Drug Combination; Dexlansoprazole; Dipyridamole; Lansoprazole

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