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.
Purpose:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
60
Aggrenox 1 capsule twice daily for 7 days
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
9.197.001 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
Plasma Dipyridamole Maximum Concentration (Cmax)
Maximum measured concentration of dipyridamole in plasma
Time frame: 7 days
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
Time frame: 7 days
Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Time frame: 7 days
Plasma Dipyridamole Minimum Concentration (Cmin)
Minimum measured concentration of dipyridamole in plasma
Time frame: 7 days
Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Time frame: 7 days
Percentage Peak-to-trough Fluctuation (%PTF)
PTF = 100\*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.
Time frame: 7 days
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omeprazole 80 once daily for 7 days