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Completed

NCT Number: NCT02376608

Bioavailability of Omega-3 Food Supplement in Healthy Subjects

The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.

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Key information

Conditions

Biological Availability

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males or females
  • any ethnic origin
  • BMI 18.5 - 30.0 kg/m2
  • generally in good health
  • signed informed consent

Exclusion criteria

  • males or females not willing to use appropriate contraception
  • 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  • earlier participated in or withdrawn from the study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

Treatment and study plan

Pronova Pure 150:500 EE EU

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.

    Time frame: Pharmacikinetics up to 36 hours post-dose

  2. Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.

    Time frame: Pharmacikinetics up to 36 hours post-dose

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: During entire study period, an expected average of 7 weeks from screening to last visit.

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Registry information

Official study title

Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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