CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Aggrenox alone +3 moredrug
Likely dose
Aggrenox and omeprazole 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01303445
NCT01303445Phase 1Completed

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)

Boehringer Ingelheim·interventional·Posted Feb 24, 2011·Updated Dec 24, 2013

In Brief

A Phase 1 clinical trial evaluating Aggrenox alone, Aggrenox and omeprazole, and 1 other intervention for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.4 years ago

Interventions

Aggrenox alonedrug

Aggrenox 1 capsule twice daily for 7 days

Aggrenox and omeprazoledrug

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

Aggrenox and omeprazoledrug

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

Omeprazole alonedrug

omeprazole 80 once daily for 7 days