Study identifier:OM-EPA-006
ClinicalTrials.gov identifier:NCT01431690
EudraCT identifier:N/A
CTIS identifier:N/A
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
Hypertriglyceridemia
Phase 1
Yes
warfarin, omefas, omega-3-acid ethyl esters
All
52
Interventional
18 Years - 55 Years
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Tempe, Arizona, United States, 85283
Arms | Assigned Interventions |
---|---|
Experimental: Warfarin and Epanova | Drug: warfarin A single 25 mg dose of warfarin Other Name: coumarin-based anticoagulant Drug: omefas 4 x 1 g capsule dose of Epanova® Other Name: Epanova |
Active Comparator: Lovaza | Drug: omega-3-acid ethyl esters 4 x 1 g capsule dose of Lovaza® Other Name: Lovaza |
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