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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aggrenox alone; Drug: Omeprazole alone; Drug: Aggrenox and omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01303445

9.197

Details and patient eligibility

About

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.

Full description

Purpose:

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 4 patient groups

Treatment A

Active Comparator group

Description:

Aggrenox alone

Treatment:

Drug: Aggrenox alone

Treatment B

Experimental group

Description:

Aggrenox and omeprazole

Treatment:

Drug: Aggrenox and omeprazole

Drug: Aggrenox and omeprazole

Treatment C

Active Comparator group

Description:

Omeprazole alone

Treatment:

Drug: Omeprazole alone

Treatment D

Experimental group

Description:

Aggrenox and omeprazole

Treatment:

Drug: Aggrenox and omeprazole

Drug: Aggrenox and omeprazole