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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
oral tablets; two ezetimibe placebo once daily for 14 days
Percent change from baseline in total cholesterol, LDL-C, HDL-C, and triglycerides.
Time frame: Day 15
Safety: adverse events, laboratory test results, physical examination, vital signs.
Time frame: Throughout study
Evaluate potential for PK interaction between ezetimibe and rosuvastatin as indicated by Cmax and AUC.
Time frame: Day 14
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oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days