Bioavailability of Omega-3 Food Supplements in Healthy Subjects
February 25, 2015 updated by: Pronova BioPharma
Nutrition Products - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements Under Fasting Conditions in Healthy Male and Female Subjects
The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects.
Each subject will participate in 5 treatment periods.
The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period.
On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing.
Twenty-four subjects will be enrolled to complete dosing of 20 subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leeds, United Kingdom, LS2 9LH
- Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males or females
- any ethnic origin
- age 40 - 65 years
- 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 taken within 14 days
- taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
- taken any medication including St. John's Worth known to alter drug absorption within 30 days
- subjects participating in a clinical study past 3 months
- recent blood donation
- significant history of drug allergy or any allergic disease
- allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
- high consumption of tobacco
- high consumption of alcohol
- other significant medical history or physical findings (including HIV,hepatitis)
- vegetarians
- not willing to follow dietary restrictions
- frequent migraine attacks
- previously taken part in or withdrawn from study or according to investigator should not participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PronovaPure 150:500 triglycerides
3 × PronovaPure 150:500 triglycerides (TG) European Union (EU)
|
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
|
|
Active Comparator: Pronovum PRF-048
3 × Pronovum PRF-048
|
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
|
|
Active Comparator: Pronovum PRF-037
3 × Pronovum PRF-037
|
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
|
|
Active Comparator: PronovaPure 500:200 TG
3 × PronovaPure 500:200 TG EU
|
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
|
|
Active Comparator: Pronovum PRF-047
3 × Pronovum PRF-047
|
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period.
The order of treatments will be in accordance with the randomisation schedule.
Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area under curve of omega-3 based dietary supplements under fasted conditions.
Time Frame: Pharmacokinetics up to 36 hours postdose
|
Pharmacokinetics up to 36 hours postdose
|
|
Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.
Time Frame: Pharmacokinetics up to 36 hours postdose
|
Pharmacokinetics up to 36 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashley Brooks, MD, Covance Clinical Research Unit (CRU) Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 11, 2015
First Submitted That Met QC Criteria
February 25, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Estimate)
March 3, 2015
Last Update Submitted That Met QC Criteria
February 25, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- CTN00714102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.