Drug Interaction Study of Clopidogrel and Rosuvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01469416
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin Drug: Clopidogrel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Study Start Date : March 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Rosuvastatin Drug: Rosuvastatin
Rosuvastatin 20 mg PO x 1

Experimental: Rosuvastatin + clopidogrel Drug: Rosuvastatin
Rosuvastatin 20 mg PO x 1

Drug: Clopidogrel
Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)

Primary Outcome Measures :
  1. Area-under-the-concentration curve (AUC) of rosuvastatin [ Time Frame: Blood samples collected over a 48 hour period ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of rosuvastatin [ Time Frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose ]
  2. Time to concentration maximum (Tmax) of rosuvastatin [ Time Frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01469416

United States, California
Clinical Research Center, UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01469416     History of Changes
Other Study ID Numbers: 11-07522
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by University of California, San Francisco:
drug interaction
healthy volunteer
drug transporter

Additional relevant MeSH terms:
Rosuvastatin Calcium
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors