Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01303445
First received: February 23, 2011
Last updated: November 27, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Aggrenox alone
Drug: Aggrenox and omeprazole
Drug: Omeprazole alone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Plasma Dipyridamole Maximum Concentration (Cmax) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Maximum measured concentration of dipyridamole in plasma

  • Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state

  • Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).


Secondary Outcome Measures:
  • Plasma Dipyridamole Minimum Concentration (Cmin) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Minimum measured concentration of dipyridamole in plasma

  • Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

  • Percentage Peak-to-trough Fluctuation (%PTF) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.


Enrollment: 60
Study Start Date: March 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Aggrenox alone
Drug: Aggrenox alone
Aggrenox 1 capsule twice daily for 7 days
Experimental: Treatment B
Aggrenox and omeprazole
Drug: Aggrenox and omeprazole
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
Active Comparator: Treatment C
Omeprazole alone
Drug: Omeprazole alone
omeprazole 80 once daily for 7 days
Experimental: Treatment D
Aggrenox and omeprazole
Drug: Aggrenox and omeprazole
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01303445

Locations
United States, Arizona
9.197.001 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01303445     History of Changes
Other Study ID Numbers: 9.197
Study First Received: February 23, 2011
Results First Received: April 24, 2012
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Aspirin, dipyridamole drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 23, 2014