Study identifier:D5880C00003
ClinicalTrials.gov identifier:NCT02189252
EudraCT identifier:N/A
CTIS identifier:N/A
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
severe hypertriglyceridemia
Phase 1
No
Epanova, Lovaza
All
30
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2016 by AstraZeneca
AstraZeneca
-
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®.
Location
Location
Philadelphia, PA, United States
Location
Kansas City, KS, United States
Location
Chocoutimi, Quebec, Canada
Location
Cincinnati, OH, United States
Arms | Assigned Interventions |
---|---|
Active Comparator: E4:L4 Crossover Sequence | - |
Active Comparator: L4:E4 Crossover Sequence | - |
Active Comparator: E2:L4 Crossover Sequence | - |
Active Comparator: L4:E2 Crossover Sequence | - |
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