Clinical trial NCT01208961: Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Radiant Research
First posted: 2010-09-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)
timeFrame: 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.
measure: AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity
timeFrame: 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.
measure: C(Max): Maximum Plasma Concentration
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
Study officials:
References:
citation: Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.