Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With H… (NCT00651144) | Clinical Trial Compass
CompletedPhase 1
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)
40 participantsStarted 2003-03
Plain-language summary
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Males and females between the ages of 18 and 55 years inclusive, having a Body Mass Index (BMI) between 19-31 inclusive. BMI=weight (kg)/height (m\^2).
* Subjects must have untreated hypercholesterolemia with a directly measured fasting LDL-C \>=130 mg/dL (3.37 mmol/L) at Screening and on Day -1. Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
* Subjects must have a normal or clinically acceptable physical exam and ECG (12-lead recorded at 25 mm/s and reporting heart rate and PR, QRS, QT, and QTc intervals).
* Subjects' clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/ sponsor.
* Screen for drugs with high potential for abuse must be negative.
* Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
* Subjects must be willing to comply with the NCEP Step 1 diet for at least one week as outpatients, and during the inpatient treatment period.
* Female subjects must be of nonchildbearing potential (ie, surgically sterilized or postmenopausal for at least one year), or, if they are of childbearing potential they must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females of childbearing…
What they're measuring
1
Percent change from baseline in total cholesterol, LDL-C, HDL-C, and triglycerides.
Timeframe: Day 15
2
Safety: adverse events, laboratory test results, physical examination, vital signs.