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NCT03443076 · ClinicalTrials.gov registry record · NA

Bioavailability of EPA + DHA in a SMEDS Formulation

A NA study of Bioavailability, sponsored by Midwest Center for Metabolic and Cardiovascular Research.

Completed
Registry status
NA
Development phase
24
Enrollment target
2
Study locations

NCT03443076 is a NA study of Bioavailability that has completed, run by Midwest Center for Metabolic and Cardiovascular Research. The registered enrollment target is 24 participants, below the 35-participant average among 8 other Bioavailability trials with a reported enrollment target (31% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03443076, a NA study of Bioavailability, has completed, sponsored by Midwest Center for Metabolic and Cardiovascular Research.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • DIETARY_SUPPLEMENT EPA + DHA in SMEDS Formulation
  • OTHER Lovaza (active comparator; already FDA approved)

Study Locations (2)

Florida

  • MB Clinical Research, LLC - Boca Raton

Illinois

  • Great Lakes Clinical Trials - Chicago

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-02-16
Est. Completion 2018-04-15
Phase NA

What the Registry Record Tells You About NCT03443076

The ClinicalTrials.gov registry entry for NCT03443076 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 35-participant average among 8 other Bioavailability trials with a reported enrollment target (31% lower). The listed sponsor is Midwest Center for Metabolic and Cardiovascular Research, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bioavailability appearing as the primary indexed condition, and to 2 interventions - of which EPA + DHA in SMEDS Formulation is the first listed.

NCT03443076 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT03443076 about?

NCT03443076 is a clinical study titled "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.

What is the current status of trial NCT03443076?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2018-02-16. Estimated completion is 2018-04-15.

What conditions does trial NCT03443076 study?

This clinical trial studies the following conditions: Bioavailability.

What interventions are being tested in trial NCT03443076?

The interventions under investigation include: EPA + DHA in SMEDS Formulation (DIETARY_SUPPLEMENT), Lovaza (active comparator; already FDA approved) (OTHER).

Who is sponsoring clinical trial NCT03443076?

This trial is sponsored by Midwest Center for Metabolic and Cardiovascular Research, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03443076 being conducted?

This trial has 2 study locations across Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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