Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals
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|ClinicalTrials.gov Identifier: NCT01431690|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : April 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertriglyceridemia||Drug: warfarin Drug: omefas Drug: omega-3-acid ethyl esters||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Experimental: Warfarin and Epanova||
A single 25 mg dose of warfarin
Other Name: coumarin-based anticoagulant
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
- Pharmacokinetics of R- and S- warfarin [ Time Frame: 168 hours ]The primary endpoints of this study will be the area under the curve (AUC)0-t, AUC0-inf, and maximum concentration (Cmax) of R- and S warfarin and the maximum International Normalized Ratio (INRmax) over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
- Pharmacodynamics of R- and S- warfarin [ Time Frame: 168 hours ]The INRmax over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
- Total EPA+DHA [ Time Frame: 24 hours ]The AUC0-tau and Cmax of baseline-adjusted total EPA+DHA following multiple doses (14 days) of Epanova® and Lovaza®.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431690
|United States, Arizona|
|Tempe, Arizona, United States, 85283|
|Study Director:||Michael H Davidson, MD, FACC||Omthera Pharmaceuticals, Inc|