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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PronovaPure 150:500 triglycerides | Active Comparator | 3 × PronovaPure 150:500 triglycerides (TG) European Union (EU) |
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| Pronovum PRF-048 | Active Comparator | 3 × Pronovum PRF-048 |
|
| Pronovum PRF-037 | Active Comparator | 3 × Pronovum PRF-037 |
|
| PronovaPure 500:200 TG | Active Comparator | 3 × PronovaPure 500:200 TG EU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PronovaPure 150:500 triglycerides | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve of omega-3 based dietary supplements under fasted conditions. | Pharmacokinetics up to 36 hours postdose | |
| Peak plasma concentration of omega-3 based dietary supplements under fasted conditions. | Pharmacokinetics up to 36 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Brooks, 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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| ID | Term |
|---|---|
| D014280 | Triglycerides |
| ID | Term |
|---|---|
| D005989 | Glycerides |
| D008055 | Lipids |
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| Pronovum PRF-047 | Active Comparator | 3 × Pronovum PRF-047 |
|
|
| Pronovum PRF-048 | Dietary Supplement | 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 |
|
| Pronovum PRF-037 | Dietary Supplement | 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 |
|
| PronovaPure 500:200 TG | Dietary Supplement | 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 |
|
| Pronovum PRF-047 | Dietary Supplement | 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 |
|