Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014

Interventions

  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Dietary Supplement: 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

Arms, Groups and Cohorts

  • Active Comparator: Pronova Pure 150:500 EE EU
    • 2 × PronovaPure 150:500 EE EU
  • Active Comparator: Pronovum PRF-037
    • 2 × Pronovum PRF-037
  • Active Comparator: Pronovum PRF-041
    • 2 × Pronovum PRF-041
  • Active Comparator: Eskimo-3
    • 3 × Eskimo-3

Clinical Trial Outcome Measures

Primary Measures

  • Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.
    • Time Frame: Pharmacikinetics up to 36 hours post-dose
  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pronova BioPharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adam Strong, MD, Principal Investigator, Covance Clinical Research Unit (CRU) Ltd.

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