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

A Randomized, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Epanova
DRUG	Lovaza

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-07-14
• Last updated: 2016-06-20
• Results posted: 2016-06-20

Locations

4 sites across 2 countries: United States, Canada