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Bioavailability of EPA + DHA in a SMEDS Formulation

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ClinicalTrials.gov Identifier: NCT03443076
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Pharmavite
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: EPA + DHA in SMEDS Formulation Drug: Lovaza Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 16, 2018
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPA + DHA in SMEDS Formulation
Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation
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

Active Comparator: EPA + DHA (Lovaza)
Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza
Drug: Lovaza
A single dose of 840 mg EPA + DHA administered as Lovaza




Primary Outcome Measures :
  1. Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours [ Time Frame: 0-24 h on Days 0-1 and on Days 14-15 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443076


Locations
United States, Florida
MB Clinical Research, LLC
Boca Raton, Florida, United States, 33487
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Sponsors and Collaborators
Midwest Center for Metabolic and Cardiovascular Research
Pharmavite
Investigators
Study Director: Kevin C Maki, PhD MB Clinical Research, LLC

Responsible Party: Midwest Center for Metabolic and Cardiovascular Research
ClinicalTrials.gov Identifier: NCT03443076     History of Changes
Other Study ID Numbers: MB-1705
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No