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Trial record 40 of 730 for:    Area Under Curve AND Bioavailability

Bioavailability of Omega-3 Food Supplement in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376608
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Pronova BioPharma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Biological Availability Dietary Supplement: Pronova Pure 150:500 EE EU Dietary Supplement: Pronovum PRF-037 Dietary Supplement: Pronovum PRF-041 Dietary Supplement: Eskimo-3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects.
Study Start Date : August 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pronova Pure 150:500 EE EU
2 × PronovaPure 150:500 EE EU
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

Active Comparator: Pronovum PRF-037
2 × Pronovum PRF-037
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

Active Comparator: Pronovum PRF-041
2 × Pronovum PRF-041
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

Active Comparator: Eskimo-3
3 × Eskimo-3
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376608


Locations
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United Kingdom
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Pronova BioPharma
Investigators
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Principal Investigator: Adam Strong, MD Covance Clinical Research Unit (CRU) Ltd.

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Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT02376608     History of Changes
Other Study ID Numbers: CTN00714101
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: August 2014