Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.
We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.
healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.
All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.
Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.
Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.
|Aspirin Blood Level Proton Pump Inhiditor Treatment||Drug: aspirin and omeprazole|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.|
- Aspirin Level in Blood (Area Under the Curve) [ Time Frame: on day 7,on day 21 ]
- Platelet Function Tests [ Time Frame: on day 0 as a baseline and on day 7 and 21 of the study. ]
|Study Start Date:||March 2007|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Drug: aspirin and omeprazole
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061034
|Assaf Harofeh Medical Center|
|Study Director:||ahuva golik, prop.||asaf-harofemedical center|