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OpenTrials
Completed

NCT Number: NCT03443076

Bioavailability of EPA + DHA in a SMEDS Formulation

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MB Clinical Research, LLC, Boca Raton, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EPA + DHA in SMEDS Formulation

Dietary Supplement

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

Lovaza (active comparator; already FDA approved)

Other

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.

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

Sponsors and collaborators

Lead sponsor

Midwest Center for Metabolic and Cardiovascular Research

Other

Collaborators

  • Pharmavite LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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