Bioavailability of EPA + DHA in a SMEDS Formulation

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Other: Lovaza (active comparator; already FDA approved); Dietary Supplement: EPA + DHA in SMEDS Formulation

• Registration Number: NCT03443076
• Lead Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-16
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Primary Completion: 2018-04-05
• Study Completion: 2018-04-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EPA + DHA (Lovaza)	Lovaza (active comparator; already FDA approved)	Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza
EPA + DHA in SMEDS Formulation	EPA + DHA in SMEDS Formulation	Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours	0-24 h on Days 0-1 and on Days 14-15

Trial Locations

Locations (2)

MB Clinical Research, LLC; 🇺🇸 Boca Raton, Florida, United States

Great Lakes Clinical Trials; 🇺🇸 Chicago, Illinois, United States