Assessment of PCSO-524 Relative to a Comparator Product
NCT ID: NCT01564160
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2012-04-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day) bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of healthy adult participants.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: PCSO-524
PCSO-524
PCSO-524
Extract of Greenshell Mussel
Arm 2: Fish Oil
Fish Oil
Fish Oil
Source of omega-3 fatty acids.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fish Oil
Source of omega-3 fatty acids.
PCSO-524
Extract of Greenshell Mussel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The participant is willing and able to comply with all requirements defined within this protocol.
* The individual is willing to provide written informed consent
* The individual is male or female
* The individual is between 18 and 65 years of age
* The individual's blood EPA+DPA+DHA ≤ 5.2% at screening
Exclusion Criteria
* The individual has taken omega-3 supplements within 3 months of screening.
* Supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea
* The individual's blood EPA+DPA+DHA ≥ 5.2% at screening
* The individual is female and pregnant or breastfeeding, or plans to be during the trial period
* The individual has known allergies product ingredients (fish/seafood)
* The individual has any significant medical illness or condition
* The individual has reported a history of drug dependence or substance abuse (excluding nicotine)
* The individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.)
* The individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit
* The individual will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmalink International Ltd.
UNKNOWN
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maggie D Laidlaw, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Nutrasource Diagnostics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nutrasource Diagnostics Inc
Guelph, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
176412
Identifier Type: OTHER
Identifier Source: secondary_id
12-02-003
Identifier Type: OTHER
Identifier Source: secondary_id
11.0202
Identifier Type: -
Identifier Source: org_study_id