Hypertriglyceridemia Clinical Trial
Official title:
An Open-label, 2-cohort Study to Evaluate the Effect of Multiple Doses of Epanova® on the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple-dose Administrations of Epanova® Compared to Lovaza® in Healthy Normal Subjects
The primary objective of this study is to determine the effect of Epanova® on the
pharmacokinetic and anticoagulant activity of warfarin.
The secondary objective of this study is to compare the systemic exposure of EPA and DHA
following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a
mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are
likely to be administered to patients with cardiovascular disease who are recommended to
consume low-fat meals.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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