Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers
Condition: Healthy
Intervention: Aggrenox alone; Aggrenox and omeprazole; Aggrenox and omeprazole; Omeprazole alone
Intervention description: Aggrenox 1 capsule twice daily for 7 days; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days; omeprazole 80 once daily for 7 days
Intervention MeSH terms: Omeprazole; Aspirin, Dipyridamole Drug Combination
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate if a drug-drug interaction occurs with
      the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of
      dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition
      (components of Aggrenox®) when administered every 12 hours at steady state.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males and females according to the following criteria:

             Based upon a complete medical history, including the physical examination, vital signs
             (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests

          2. BMI >18.5 and BMI <32 kg/m2 (Body Mass Index)

        Exclusion criteria:

          1. Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance in the opinion of the PI

          2. Any evidence of a clinically relevant concomitant disease

          3. Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular,
             metabolic, immunological, hormonal, or hematologic (including a history of abnormal
             bruising) disorders in the opinion of the PI

          4. Surgery of the gastrointestinal tract that might impair drug absorption

          5. Clinically significant diseases of the central nervous system (such as epilepsy) or
             psychiatric disorders or neurological disorders

          6. History of relevant orthostatic hypotension, fainting spells or blackouts.

          7. Chronic or relevant acute infections

          8. History of relevant allergy/hypersensitivity (including allergy to study drugs or its
             excipients, or reactions to related drugs [e.g., non-steroidal anti-inflammatory
             drugs])

          9. Intake of drugs with a long half-life (¿24 hours) within one month, or less than 10
             half lives of the respective drug, prior to study drug administration or during the
             trial

         10. Use of drugs which might reasonably influence the results of the trial (including OTC
             antacids) based on the knowledge at the time of protocol preparation within 14 days
             prior to administration or during the trial

         11. Participation in another trial with an investigational drug within two months prior to
             administration or during the trial

         12. Tobacco use within the 90 days prior to check-in and throughout the study

         13. Alcohol abuse within the past 2 years

         14. Drug abuse within the past 2 years

         15. Blood donation or other significant blood loss within 56 days (inclusive) prior to
             screening, or plasma donation within 7 days (inclusive) prior to study drug
             administration, or during the trial

         16. Excessive physical activities (within one week prior to first drug administration or
             during the trial)

         17. Any laboratory value outside the reference range that is of clinical relevance in the
             opinion of the PI; including positive virology, or urine drug screen, or positive
             fecal occult blood test

         18. Inability to comply with dietary regimen of trial site

         19. In the opinion of the investigator it would be in the best interest of the subject to
             be excluded from participation.