Wednesday, September 28, 2016 2:55:18 PM
"Objectives: The primary objective of this study was to determine the 2-way interaction between
multiple oral doses of Epanova™ (omega-3 free fatty acids) and a single oral dose of
rosuvastatin (Crestor®) administered after a low-fat meal.
The secondary objective of this study was to assess the dose-proportionality of
baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure following
multiple administrations of 2 different oral doses (2 g and 4 g) of Epanova™ administered after a
low-fat meal.
The tertiary objective of this study was to compare the systemic exposure of baseline-adjusted
(primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total
EPA+DHA following multiple oral doses of Epanova™ (2 g and 4 g once daily [QD]) and
Vascepa® (2 g twice daily [BID]) administered after a low-fat meal.
The exploratory objective of this study was to evaluate the percentage changes in lipid
parameters (triglycerides [TGs], high-density lipoprotein cholesterol [HDL-C], low-density
lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], and
apolipoprotein-CIII [apo-CIII]) from baseline following multiple oral doses of Epanova™ (2 g and
4 g QD) and Vascepa® (2 g BID) administered after a low-fat meal."
https://clinicaltrials.gov/ct2/show/NCT02859129?term=Vascepa&rank=4
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