Conditions: Severe Hypertriglyceridemia
Keywords: Eicosapentaenoic Acid Docosahexaenoic Acid Hypertriglyceridemia Omega-3 acid ethyl esters Omega-3 carboxylic acids Epanova Lovaza bioavailability pharmacokinetics low-fat meal high-fat meal
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Epanova (4 g) and Lovaza (4 g) intervention 2: Lovaza (4 g) and Epanova (4 g)
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: