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

NCT01303445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-12-24

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Aggrenox alone

Aggrenox 1 capsule twice daily for 7 days

DRUG

Aggrenox and omeprazole

Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days

DRUG

Aggrenox and omeprazole

Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days

DRUG

Omeprazole alone

omeprazole 80 once daily for 7 days

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303445 on ClinicalTrials.gov