Clinical trial NCT03443076: Bioavailability of EPA + DHA in a SMEDS Formulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Lead sponsor: Midwest Center for Metabolic and Cardiovascular Research
Sponsor class: OTHER
Collaborators: name: Pharmavite LLC
First posted: 2018-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours
timeFrame: 0-24 h on Days 0-1 and on Days 14-15
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: MB Clinical Research, LLC
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
Study officials:
affiliation: MB Clinical Research, LLC
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
citation: Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard omega-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State. Clin Ther. 2018 Dec;40(12):2065-2076. doi: 10.1016/j.clinthera.2018.10.014. Epub 2018 Nov 16.