Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Study Overview
=================
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.

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.

Conditions
-----------------
Biological Availability

Intervention / Treatment
-----------------
* Dietary Supplement: Pronova Pure 150:500 EE EU
* Dietary Supplement: Pronovum PRF-037
* Dietary Supplement: Pronovum PRF-041
* Dietary Supplement: Eskimo-3


Participation Criteria
=================
Eligibility 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high consumption of alcohol high consumption of tobacco hepatitis or HIV vegetarians earlier participated in or withdrawn from the study not willing to follow dietary restrictions frequent occurence of migraine attacks subjects that should not participate according to investigator

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pronova Pure 150:500 EE EU<br>2 × PronovaPure 150:500 EE EU | Dietary Supplement: Pronova Pure 150:500 EE EU<br>* 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<br>Dietary Supplement: Pronovum PRF-037<br>* 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<br>Dietary Supplement: Pronovum PRF-041<br>* 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<br>Dietary Supplement: Eskimo-3<br>* 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<br>|
| Active Comparator: Pronovum PRF-037<br>2 × Pronovum PRF-037 | Dietary Supplement: Pronova Pure 150:500 EE EU<br>* 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<br>Dietary Supplement: Pronovum PRF-037<br>* 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<br>Dietary Supplement: Pronovum PRF-041<br>* 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<br>Dietary Supplement: Eskimo-3<br>* 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<br>|
| Active Comparator: Pronovum PRF-041<br>2 × Pronovum PRF-041 | Dietary Supplement: Pronova Pure 150:500 EE EU<br>* 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<br>Dietary Supplement: Pronovum PRF-037<br>* 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<br>Dietary Supplement: Pronovum PRF-041<br>* 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<br>Dietary Supplement: Eskimo-3<br>* 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<br>|
| Active Comparator: Eskimo-3<br>3 × Eskimo-3 | Dietary Supplement: Pronova Pure 150:500 EE EU<br>* 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<br>Dietary Supplement: Pronovum PRF-037<br>* 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<br>Dietary Supplement: Pronovum PRF-041<br>* 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<br>Dietary Supplement: Eskimo-3<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of omega-3 food supplements under light fed conditions in healthy subjects. |  | Pharmacikinetics up to 36 hours post-dose | 
| Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects. |  | Pharmacikinetics up to 36 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability. |  | During entire study period, an expected average of 7 weeks from screening to last visit. |