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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 LLC
Information provided by (Responsible Party):
Midwest Center for Metabolic and Cardiovascular Research

Tracking Information
First Submitted Date  ICMJE February 16, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE February 16, 2018
Actual Primary Completion Date April 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03443076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of EPA + DHA in a SMEDS Formulation
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Bioavailability
Intervention  ICMJE
  • 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
  • Drug: Lovaza
    A single dose of 840 mg EPA + DHA administered as Lovaza
Study Arms  ICMJE
  • Experimental: EPA + DHA in SMEDS Formulation
    Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation
    Intervention: Dietary Supplement: EPA + DHA in SMEDS Formulation
  • Active Comparator: EPA + DHA (Lovaza)
    Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza
    Intervention: Drug: Lovaza
Publications * Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard ω-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2018
Actual Primary Completion Date April 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443076
Other Study ID Numbers  ICMJE MB-1705
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Midwest Center for Metabolic and Cardiovascular Research
Study Sponsor  ICMJE Midwest Center for Metabolic and Cardiovascular Research
Collaborators  ICMJE Pharmavite LLC
Investigators  ICMJE
Study Director: Kevin C Maki, PhD MB Clinical Research, LLC
PRS Account Midwest Center for Metabolic and Cardiovascular Research
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP