MedTrace Logo

Bioavailability of EPA + DHA in a SMEDS Formulation

NCT03443076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-03-23

No results posted yet for this 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.

Conditions

  • Bioavailability

Interventions

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

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.

Sponsors & Collaborators

  • Pharmavite LLC

    collaborator INDUSTRY

  • Midwest Center for Metabolic and Cardiovascular Research

    lead OTHER

Principal Investigators

  • Kevin C Maki, PhD · MB Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2018-04-05
Completion
2018-04-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443076 on ClinicalTrials.gov