Aspirin Blood Level Clinical Trial
Official title:
The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
| Verified date | November 2009 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | June 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf Harofeh Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Aspirin Level in Blood (Area Under the Curve) | on day 7,on day 21 | No | |
| Secondary | Platelet Function Tests | on day 0 as a baseline and on day 7 and 21 of the study. | No |