Bioavailability of Omega-3 Food Supplement in Healthy Subjects
NCT ID: NCT02376608
Last Updated: 2015-03-03
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
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-08-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
Pronova Pure 150:500 EE EU
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
2 × Pronovum PRF-037
Pronova Pure 150:500 EE EU
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
2 × Pronovum PRF-041
Pronova Pure 150:500 EE EU
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
3 × Eskimo-3
Pronova Pure 150:500 EE EU
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Interventions
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Pronova Pure 150:500 EE EU
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-037
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Pronovum PRF-041
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eskimo-3
Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
Eligibility Criteria
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Inclusion Criteria
* any ethnic origin
* BMI 18.5 - 30.0 kg/m2
* generally in good health
* signed informed consent
Exclusion Criteria
* prescribed systemic or topical medication within 14 days and slow release medication considered to be active within 14 days.
* omega-3 fatty acids or fish oil within 2 weeks of dosing.
* any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
* any medication incl. St.John's Worth known to chronically alter drug absorption/elimination within 30 days
* Subjects still present in clinical study or in the past 3 months
* recent blood donation
* drug allergy or significant allergic disease
* allergic or hypersensitivity to omega-3 acids, fish, soya, oleic acid, sesame oil or other constituents in pharma preparation
* high consumption of alcohol
* high consumption of tobacco
* hepatitis or HIV
* vegetarians
* earlier participated in or withdrawn from the study
* not willing to follow dietary restrictions
* frequent occurence of migraine attacks
* subjects that should not participate according to investigator
Yes
Sponsors
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Pronova BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Strong, MD
Role: PRINCIPAL_INVESTIGATOR
Covance Clinical Research Unit (CRU) Ltd.
Locations
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Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, , United Kingdom
Countries
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Other Identifiers
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CTN00714101
Identifier Type: -
Identifier Source: org_study_id
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