Food-associated pharmacokinetic differences and variability of a rosuvastatin/ezetimibe fixed-dose combination in replicated bioequivalence studies.
BACKGROUND /OBJECTIVES Rosuvastatin/ezetimibe fixed-dose combinations target cholesterol synthesis and intestinal absorption, but pharmacokinetics may differ by analyte, endpoint, and fasted/fed state. This study characterized food-associated pharmacokinetic differences, reference-product within-subject variability, an...