Drug Interaction Study of Clopidogrel and Rosuvastatin
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | March 2012 |
End Date: | December 2012 |
Contact: | Connie Remsberg, PharmD, PhD |
Email: | remsbergc@medsfgh.ucsf.edu |
Phone: | 415-476-5890 |
The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport
of rosuvastatin clinically.
Inclusion Criteria:
- Healthy individuals, male or female, age 18-65 years old, with no current medical
conditions or active diagnoses as determined by the study doctor based on history,
physical exam and laboratory evaluations
- Subjects that take no other medications 2 weeks prior to the study and during the
time course of the study including prescription medications, over-the-counter
medications (except acetaminophen), dietary supplements, or drugs of abuse
- Subjects with a SLCO1B1*1A genotype
- Subjects able to maintain adequate birth control during the study independent of
hormonal contraceptive use
- Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated
beverages and/or alcoholic beverages from 3 pm the day before the study to completion
of that study day.
- Participants determined to have normal liver and kidney function as measured at
baseline
- BMI between 18.5 - 30 kg/m2
- Subjects capable of fasting from food and beverages at least 8 hours prior to
medication dosing
- Be able to read, speak, and understand English
Exclusion Criteria:
- Subjects with active medical problems
- Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks
prior to and during the study.
- Subjects incapable of multiple blood draws (HCT <30 mg/dL)
- Subjects with a history of rhabdomyolysis
- Subjects with a history of drug-related myalgias
- Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias
- Subjects with a history of GI bleed or peptic ulcer disease
- Subjects with a recent history of trauma
- Subjects with a recent history of or upcoming plan of surgery
- Subjects that smoke tobacco or have ongoing alcohol or illegal drug use
- Subjects who are pregnant, lactating, or trying to conceive during the study period
- Subjects allergic to rosuvastatin or clopidogrel or any known component of the
medications
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