Study identifier:OM-EPA-001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
severe hypertriglyceridemia
Phase 2
Yes
Epanova (4 g) and Lovaza (4 g), Lovaza (4 g) and Epanova (4 g)
All
54
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Radiant Research
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Epanova-Lovaza-Epanova-Lovaza | 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 Other Name: Note that omefas corresponds to omega-3 carboxylic acids |
Active Comparator: Lovaza-Epanova-Lovaza-Epanova | 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 Other Name: Note that omefas corresponds to omega-3 carboxylic acids |