Skip to main content
OpenTrials
Completed

NCT Number: NCT01469416

Drug Interaction Study of Clopidogrel and Rosuvastatin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Center, UCSF

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 20 mg PO x 1

clopidogrel

Drug

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

Primary outcomes

  1. Area-under-the-concentration curve (AUC) of rosuvastatin

    Time frame: Blood samples collected over a 48 hour period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2011
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.