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CompletedNCT03443076Updated Mar 23, 2023

Bioavailability of EPA + DHA in a SMEDS Formulation

An interventional study of EPA + DHA in SMEDS Formulation and Lovaza (active comparator; already FDA approved) in Bioavailability, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bioavailability
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • Dietary supplementEPA + DHA in SMEDS Formulation

    A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation

  • OtherLovaza (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.

05

What researchers measure

Primary outcomes

  1. Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours

    Time frame: 0-24 h on Days 0-1 and on Days 14-15

06

Study locations

2 sites
  • MB Clinical Research, LLC
    Boca Raton, Florida 33487, United States
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
07

References and documents

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. PubMed 30454850 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03443076
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Pharmavite LLC
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 16, 2018
Primary completion
Apr 5, 2018
Completion
Apr 15, 2018
Last update
Mar 23, 2023

Study contacts

Kevin C Maki, PhD
study director · MB Clinical Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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