Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers

Not Applicable

Completed

• Conditions: Aspirin Blood Level; Proton Pump Inhiditor Treatment

• Registration Number: NCT01061034
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2009-05-03
• Results First Submitted: 2009-05-03
• Status Verified: 2009-11
• Study First Submitted QC: 2010-01-02
• Results First Submitted QC: 2010-01-02
• Last Update Submitted: 2010-01-02
• Study First Posted: 2010-02-02
• Results First Posted: 2010-02-02
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Aspirin Level in Blood (Area Under the Curve)	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 Outcome Measures

Name	Time	Method
Platelet Function Tests	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.

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel