A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM (ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®.
Clin Ther
; 39(3): 581-591, 2017 Mar.
Article
em En
| MEDLINE
| ID: mdl-28189364
ABSTRACT
PURPOSE:
The US Food and Drug Administration has approved several highly purified ω-3 fatty acid prescription drugs for the treatment of severe hypertriglyceridemia. These differ in the amounts and forms of docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). This study compared the bioavailability of SC401 (1530 mg EPA-ethyl esters [EEs] and DHA-EEs plus Advanced Lipid Technologiesâ [ALT], a proprietary lipid-delivery platform to improve absorption), with. Lovaza (3600 mg ω-3, primarily EPA-EEs and DHA-EEs) under low-fat feeding conditions.METHODS:
This was a Phase I, randomized, open-label, single-dose, 2-way crossover study in healthy participants housed from day -3 to day 2 in each treatment period. Blood samples for pharmacokinetic measurements were collected before and after dosing, and safety profile and tolerability were assessed.FINDINGS:
In unadjusted analyses, SC401 had 5% lower Cmax and approximately the same AUC0-last of EPA + DHA total lipids compared with Lovaza. When adjusted for baseline, SC401 had ~6% higher Cmax and 18% higher AUC0-last for EPA + DHA total lipids, and dose- and baseline-adjusted analyses found that SC401 had ~149% higher Cmax and 178% higher AUC0-last than Lovaza for EPA + DHA total lipids. The Tmax was also substantially longer with Lovaza (~10 hours) than with SC401 (~6 hours). IMPLICATIONS These results indicate that SC401, an ω-3 acid EE formulation containing ALT achieved high bioavailability of EPA and DHA, at a lower dose (1530 mg) than Lovaza (3600 mg), under low-fat feeding conditions.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ácidos Graxos Ômega-3
/
Ácido Eicosapentaenoico
/
Ácidos Docosa-Hexaenoicos
/
Hipolipemiantes
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Clin Ther
Ano de publicação:
2017
Tipo de documento:
Article