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

NCT01208961 | Completed Phase 2 Results

• 1 other identifier: OM-EPA-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Epanova-Lovaza-Epanova-Lovaza

ACTIVE COMPARATOR

Drug: Epanova (4 g) and Lovaza (4 g)

Lovaza-Epanova-Lovaza-Epanova

ACTIVE COMPARATOR

Drug: Lovaza (4 g) and Epanova (4 g)

Interventions

Epanova (4 g) and Lovaza (4 g) DRUG

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

Also known as: Note that omefas corresponds to omega-3 carboxylic acids

Epanova-Lovaza-Epanova-Lovaza

Lovaza (4 g) and Epanova (4 g) DRUG

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

Also known as: Note that omefas corresponds to omega-3 carboxylic acids

Lovaza-Epanova-Lovaza-Epanova

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Radiant Research: collaborator

Study Sites (1)

Radiant Research

Chicago, Illinois, 60654, United States

Location

Related Publications (1)

• 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.

  PMID: 23312053 RESULT

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Torbjörn Lundström, Medical Science Director
• Organization: AstraZeneca Pharmaceuticals

ClinicalTrialTransparency@astrazeneca.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 15, 2015
• Results First Posted: January 6, 2014

Record last verified: 2015-06

Locations

US (1)