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

Study identifier:OM-EPA-001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

severe hypertriglyceridemia

Phase

Phase 2

Healthy volunteers

Yes

Study drug

Epanova (4 g) and Lovaza (4 g), Lovaza (4 g) and Epanova (4 g)

Sex

All

Actual Enrollment

54

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Radiant Research

Inclusion and exclusion criteria