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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aggrenox and omeprazole; Drug: Omeprazole alone; Drug: Aggrenox alone

• Registration Number: NCT01303445
• Lead Sponsor: Boehringer Ingelheim

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:

Study Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Study Start: 2011-03
• Primary Completion: 2011-04
• Results First Submitted: 2012-04-24
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-23
• Results First Posted: 2012-07-24
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	Aggrenox and omeprazole	Aggrenox and omeprazole
Treatment C	Omeprazole alone	Omeprazole alone
Treatment A	Aggrenox alone	Aggrenox alone
Treatment D	Aggrenox and omeprazole	Aggrenox and omeprazole

Primary Outcome Measures

Name	Time	Method
Plasma Dipyridamole Maximum Concentration (Cmax)	7 days	Maximum measured concentration of dipyridamole in plasma
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)	7 days	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)	7 days	IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

Secondary Outcome Measures

Name	Time	Method
Percentage Peak-to-trough Fluctuation (%PTF)	7 days	PTF = 100\*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.
Plasma Dipyridamole Minimum Concentration (Cmin)	7 days	Minimum measured concentration of dipyridamole in plasma
Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)	7 days	IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

Trial Locations

Locations (1)

9.197.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Tempe, Arizona, United States