Bioavailability of EPA + DHA in a SMEDS Formulation

A Randomized, Crossover Study to Assess the Relative Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid in a Self-micro-emulsifying Delivery System (SMEDS) Formulation Compared With a Standard Omega-3-acid Ethyl Ester Product

This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: EPA + DHA in SMEDS Formulation; Other: Lovaza (active comparator; already FDA approved)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33487
      • MB Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index 18.50-29.99 kg/m2
• Good health on basis of medical history and routine laboratory tests
• Score of at least 7 on vein access scale
• Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
• Willing to abstain from alcohol for 24 h prior to clinic admission
• No plans to change smoking habits or other nicotine use
• Willing to undergo 13 venipunctures during each treatment period

Exclusion Criteria:

• Screening lab test of clinical significance
• Positive urine drug screen
• Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
• Uncontrolled hypertension
• Recent history or presence of cancer
• Difficulty swallowing capsules
• Recent blood donation or blood loss
• Recent consumption of high-dose fish oil or fish
• Recent use of any prescribed medication or over-the-counter medicinal products, including herbal or dietary supplements (except daily omega-3 fatty acid-free vitamin and/or mineral supplement or occasional use of acetaminophen or non-steroidal anti-inflammatory drugs)
• Signs or symptoms of active infection or has recently taken antibiotics
• Recent history or strong potential for drug or alcohol abuse
• Pregnant, planning to be pregnant during the study, lactating or of childbearing potential and unwilling to commit to use of a medically approved form of contraception throughout the study (note: hormonal contraceptive use is not allowed)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPA + DHA in SMEDS Formulation; Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation	Dietary supplement: EPA + DHA in SMEDS Formulation; A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation
Active Comparator: EPA + DHA (Lovaza); Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza	Other: Lovaza (active comparator; already FDA approved); A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours	0-24 h on Days 0-1 and on Days 14-15

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: Pharmavite LLC
• Investigators: Study Director: Kevin C Maki, PhD, MB Clinical Research, LLC

Publications and helpful links

General Publications

• Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard omega-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State. Clin Ther. 2018 Dec;40(12):2065-2076. doi: 10.1016/j.clinthera.2018.10.014. Epub 2018 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): April 15, 2018

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MB-1705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No