Clinical trial NCT01303445: Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Detailed description: Purpose:

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.

Primary outcomes:
measure: Plasma Dipyridamole Maximum Concentration (Cmax)
timeFrame: 7 days
measure: Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
timeFrame: 7 days
measure: Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
timeFrame: 7 days
Secondary outcomes:
measure: Plasma Dipyridamole Minimum Concentration (Cmin)
timeFrame: 7 days
measure: Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
timeFrame: 7 days
measure: Percentage Peak-to-trough Fluctuation (%PTF)
timeFrame: 7 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: 9.197.001 Boehringer Ingelheim Investigational Site
state: Arizona
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: