Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

NCT01208961 ↗

Phase 2 Completed 54 enrolled AstraZeneca Radiant Research · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

Timeline

Start: 2010-09
Primary completion: 2010-11
Completion: 2010-11

Publications

Results Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Epanova	Other / unclassified	4 g	—
Comparator	Lovaza	Other / unclassified	4 g	—

Indications

No indication recorded.