Assaf Harofeh Medical Center
Ẕerifin, Israel
Completed
NCT Number: NCT01061034
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.
Completed
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Notify MeKey information
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-healthy volunteers
Exclusion criteria
- pretreatment with aspirin
- pretreatment with non steroidal anti inflamatory drugs
- pretreatment with antacids
- history of peptic ulcer disease
- coagulation or aggregation disorder.
Treatment and study plan
aspirin and omeprazole
Drugaspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.
Primary outcomes
-
Aspirin Level in Blood (Area Under the Curve)
Time frame: on day 7,on day 21
Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.
The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin.
Secondary outcomes
-
Platelet Function Tests
Time frame: on day 0 as a baseline and on day 7 and 21 of the study.
Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.
the results reflects the percent of active platelets.
Sponsors and collaborators
Lead sponsor
Assaf-Harofeh Medical Center
Other Gov
Registry information
Official study title
The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
Important dates
- Study start
- 2007
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Feb 2, 2010
- Registry last updated
- Feb 2, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.