Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Condition: Severe Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Epanova (4 g) and Lovaza (4 g); Lovaza (4 g) and Epanova (4 g)
Intervention description: 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; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
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

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women, aged ≥18.

          -  Normal healthy volunteers based on medical history, clinical assessments, and
             laboratory assessments.

          -  Body mass index 25-35 kg/m2.

          -  Willingness to maintain current activity level.

          -  Willingness to adhere to the Therapeutic Lifestyle Changes (TLC)diet during screening
             and treatment washout periods.

        Exclusion Criteria:

          -  Intolerance to omega-3 fatty acids, ethyl esters, or fish.

          -  Unable or unwilling to eat the study meals.

          -  Use of fish oil, other EPA or DHA containing supplements, or EPA and/or DHA fortified
             foods within 60 days of Visit 2, or during the study.

          -  Consumption of any fish within 7 days of Visit 2, or during the study.

          -  Use of flaxseed, perilla seed, hemp, spirulina, or black currant oils within 7 days of
             Visit 2, or during the study.

          -  History of malabsorption syndrome, Crohn's disease, acute or chronic pancreatitis,
             pancreatic insufficiency, small bowel resection.

          -  Women who are pregnant, lactating, or planning to become pregnant during the study
             period, or women of childbearing potential who are not using acceptable contraceptive
             methods. A woman is considered of childbearing potential if she is not surgically
             sterile or is less than 1 year since last menstrual period. Examples of acceptable
             contraceptive methods include abstinence, intrauterine device (IUD) or double barrier
             method, oral or injectable contraceptives.

          -  Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be
             defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard
             liquor).

          -  Exposure to any investigational product, within 28 days prior to Visit 1.

          -  Any other condition the investigator believes would interfere with the subject's
             ability to provide informed consent, comply with study instructions, or which might
             confound the interpretation of the study results or put the subject at undue risk.