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This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.
This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loading dose. The subjects who have been randomized to receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the morning, followed two hours later by a loading dose (300 mg) of clopidogrel and will then return to the clinic 6 hours after their loading dose to have their platelet inhibition measured. Subjects will have ~ 5 milliliters (1 teaspoonful) of whole blood drawn from an antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of platelet aggregation. After their first loading dose, a 2 week washout period will follow to allow for their platelet aggregation to return to normal. Following the washout period, the subjects will take their second loading dose of clopidogrel and again return to the clinic for platelet inhibition measurement. The same timing will be followed for the loading dose taken without prior GFJ.
During the maintenance dose phase of this study, subjects will take 75 mg/day clopidogrel for 7 days with or without GFJ. Subjects will be randomized to either GFJ during the first period or GFJ during the second period. A minimum 2 week washout period will occur between the two 7 day courses of clopidogrel. Platelet inhibition measurement will occur at the end of each 7 day period as described above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loading Dose | Experimental | Participants received a 300 mg dose of clopidogrel with or without GFJ. |
|
| Maintenance Dose | Experimental | Participants received clopidogrel 75 mg/day for 7 days with or without GFJ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grapefruit juice | Dietary Supplement | Participants received grapefruit juice during 1 of the 2 periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Platelet Inhibition | % platelet inhibition measured by Verify Now | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy Burns, PharmD | Creighton Cardiac Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton Cardiac Center | Omaha | Nebraska | 68131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loading Dose | Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice. |
| FG001 | Maintenance Dose | Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grapefruit Juice |
| |||||||||||||
| No Grapefruit Juice |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loading Dose | |
| BG001 | Maintenance Dose | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Platelet Inhibition | % platelet inhibition measured by Verify Now | Posted | Mean | Standard Deviation | percentage of platelet inhibition | 6 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loading Dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Burns, PharmD | Creighton University | 402-280-4292 | TammyBurns@creighton.edu |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel 75 mg/day | Drug |
|
| Clopidogrel 300 mg | Drug |
|
| NOT COMPLETED |
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Maintenance Dose | 0 | 17 | 0 | 17 |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |