Assessment of PCSO-524 Relative to a Comparator Product
This study has been completed.
Sponsor:
Nutrasource Diagnostics Inc.
Collaborator:
Pharmalink International Ltd.
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT01564160
First received: March 22, 2012
Last updated: November 30, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 22, 2012 | ||||
| Last Updated Date | November 30, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Serum Phospholipid [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01564160 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of PCSO-524 Relative to a Comparator Product | ||||
| Official Title ICMJE | Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product. | ||||
| Brief Summary | A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids. 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 | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* 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 | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01564160 | ||||
| Other Study ID Numbers ICMJE | 11.0202, 176412, 12-02-003 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nutrasource Diagnostics Inc. | ||||
| Study Sponsor ICMJE | Nutrasource Diagnostics Inc. | ||||
| Collaborators ICMJE | Pharmalink International Ltd. | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Nutrasource Diagnostics Inc. | ||||
| Verification Date | November 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||