NCT03443076

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Midwest Center for Metabolic and Cardiovascular Research · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-02-16
• Primary completion: 2018-04-05
• Completion: 2018-04-15
• First posted: 2018-02-22
• Last updated: 2023-03-23

Locations

2 sites across 1 country: United States