An 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
Condition: Severe Hypertriglyceridemia
MeSH terms: Pancreatitis; Hypertriglyceridemia
Intervention: Epanova; Lovaza
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      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®.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, ≥18 years of age;

          2. History of serum TG concentration ≥500 mg/dL within the past 5 years;

          3. Have at least one episode of documented hospitalization for pancreatitis due to
             hypertriglyceridemia in his/her lifetime;

          4. Have no health conditions that would prevent him/her from fulfilling the study
             requirements as judged by the Investigator on the basis of physical examination, ECG,
             medical history, and routine laboratory test results;

          5. Willing to maintain his/her current activity level and to follow either the NCEP TLC
             diet with a caloric target for weight maintenance or a prescribed low-fat diet during
             the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through
             12);

          6. Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before
             and during Visits 4b and 6b (Weeks 4 and 12);

          7. Willing to abstain from alcohol consumption and avoid vigorous physical activity for
             48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and

          8. Subject understands the study procedures and is willing and able to sign the informed
             consent form to participate in the study and the Health Insurance Portability and
             Accountability Act authorization for release of relevant protected health information
             to the Investigators and study personnel.

        Exclusion Criteria:

          1. An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or
             any of the components of the standardized breakfast, lunch, or dinner meals or snacks
             (as described to them by study staff)

          2. Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100
             mmHg diastolic) prior to randomization (Visit 3 [Week 0])

          3. A history of cancer (other than basal cell carcinoma) in the last 2 years

          4. A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome,
             new onset angina, stroke, transient ischemic attack, unstable congestive heart failure
             requiring a change in treatment), aortic aneurysm or resection, carotid
             endarterectomy, or revascularization procedure within the 6 months prior to Visit 1