NCT01208961

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

A Randomized, Open-label, Four-Way Crossover Study to Compare the Relative Bioavailability of a Single Dose of Epanova® With Lovaza® After a Low-Fat and High-Fat Meal

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Epanova (4 g) and Lovaza (4 g)	Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
DRUG	Lovaza (4 g) and Epanova (4 g)	Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose ofEpanova (omefas),4x1g capsules, taken with high-fat meals

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-09-24
• Last updated: 2015-07-15
• Results posted: 2014-01-06

Locations

1 site across 1 country: United States