This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation
A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted.
MB Clinical Research, LLC
Boca Raton, Florida, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
Time frame: 0-24 h on Days 0-1 and on Days 14-15
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