This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Research Site
Kansas City, Kansas, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Chocoutimi, Quebec, Canada
Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
Cmax: Maximum measured plasma concentration over the time span specified
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total EPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total EPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DHA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DHA
Time frame: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted AUC0-24 for Plasma Total DPA
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Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Baseline-adjusted Cmax for Plasma Total DPA
Time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.