Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Severe Hypertriglyceridemia

Intervention / Treatment
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* Drug: Epanova (4 g) and Lovaza (4 g)
* Drug: Lovaza (4 g) and Epanova (4 g)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epanova-Lovaza-Epanova-Lovaza<br> | Drug: Epanova (4 g) and Lovaza (4 g)<br>* 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<br>* Other names: Note that omefas corresponds to omega-3 carboxylic acids;|
| Active Comparator: Lovaza-Epanova-Lovaza-Epanova<br> | Drug: Lovaza (4 g) and Epanova (4 g)<br>* 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<br>* Other names: Note that omefas corresponds to omega-3 carboxylic acids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ) | Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. | Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. | 
| AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity | Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. | Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. | 
| C(Max): Maximum Plasma Concentration | Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. | Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eicosapentaenoic Acid, Docosahexaenoic Acid, Hypertriglyceridemia, Omega-3 acid ethyl esters, Omega-3 carboxylic acids, Epanova, Lovaza, bioavailability, pharmacokinetics, low-fat meal, high-fat meal