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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pronova Pure 150:500 EE EU | Active Comparator | 2 × PronovaPure 150:500 EE EU |
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| Pronovum PRF-037 | Active Comparator | 2 × Pronovum PRF-037 |
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| Pronovum PRF-041 | Active Comparator | 2 × Pronovum PRF-041 |
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| Eskimo-3 | Active Comparator | 3 × Eskimo-3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Strong, MD | Covance Clinical Research Unit (CRU) Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street | Leeds | LS2 9LH | United Kingdom |
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| 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 |
|