The Impact of Grapefruit Juice on the Response to a Loading Dose and Maintenance Dose of Clopidogrel in Healthy Volunteers

This study is currently recruiting participants.

Verified by Creighton University, January 2009

First Received: January 6, 2009 No Changes Posted

Sponsored by:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00817999

Purpose

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.

Condition
Healthy

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	The Impact of Grapefruit Juice on the Response to a Loading Dose and Maintenance Dose of Clopidogrel in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Creighton University:

Estimated Enrollment:	20
Study Start Date:	November 2008

Eligibility

Ages Eligible for Study:	19 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

A healthy volunteer

Criteria

Inclusion Criteria:

Ages 19-40
Health status confirmed by medical history and physical examination and laboratory analysis

Exclusion Criteria:

Pregnancy
Taking routine prescription or over-the-counter prescriptions
Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of study participation
Recently had grapefruit juice or regularly drinks grapefruit juice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817999

Contacts

Contact: Robyn Kondrack, PharmD

402-280-4826

Locations

United States, Nebraska
Creighton Cardiac Center	Recruiting
Omaha, Nebraska, United States
Contact: Stephanie Maciejewski, PharmD 402-280-4292

Sponsors and Collaborators

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Robyn Kondrack, PharmD )
Study ID Numbers:	08-15073
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00817999 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Platelet Aggregation Inhibition

Study placed in the following topic categories:

Grapefruit Seed Extract
Clopidogrel
Platelet Aggregation Inhibitors
Healthy

Additional relevant MeSH terms:

Therapeutic Uses
Clopidogrel
Hematologic Agents
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009