The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin
Time frame: Hour 0 to Hour 48
Maximum plasma concentration (Cmax) of atorvastatin
Time frame: Hour 0 to Hour 48
Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ)
Time frame: Hour 0 to Hour 96
Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
Time frame: Hour 0 to Hour 96
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Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).