drugset / Trial / NCT02189252

An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

NCT02189252

Phase 1 Completed 30 enrolled AstraZeneca
RandomizedCrossoverOpen-labelTreatment

Summary

This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.

Timeline

Start
2014-10
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Epanova Other / unclassified 2 g
Comparator Epanova Other / unclassified 4 g
Comparator Lovaza Other / unclassified 4 g

Indications

No indication recorded.