Bioavailability of EPA + DHA in a SMEDS Formulation

Bioavailability Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443076
• Other study ID #: MB-1705
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: April 15, 2018

Study information

• Verified date: March 2023
• Source: Midwest Center for Metabolic and Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 15, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bioavailability

Intervention

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.

Locations

Country	Name	City	State
United States	MB Clinical Research, LLC	Boca Raton	Florida
United States	Great Lakes Clinical Trials	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Center for Metabolic and Cardiovascular Research	Pharmavite LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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