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 Technologies⁎ [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.
RCT Entities:
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 Technologies⁎ [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.
Authors: Ahmed A Daak; Carlton D Dampier; Beng Fuh; Julie Kanter; Ofelia A Alvarez; L Vandy Black; Melissa A McNaull; Michael U Callaghan; Alex George; Lynne Neumayr; Lee M Hilliard; Fredrick Sancilio; Adrian L Rabinowicz; Matthew M Heeney Journal: Blood Adv Date: 2018-08-14
Authors: Kristen E Bremmell; David Briskey; Tahlia R Meola; Alistair Mallard; Clive A Prestidge; Amanda Rao Journal: Eur J Nutr Date: 2019-10-21 Impact factor: 5.614
Authors: Thiago I B Lopes; Elba S Pereira; Deisy Dos S Freitas; Samuel L Oliveira; Glaucia B Alcantara Journal: J Food Sci Technol Date: 2019-11-13 Impact factor: 2.701
Authors: Yan Qin; Hilde Nyheim; Else Marie Haram; Joseph M Moritz; Svein Olaf Hustvedt Journal: Lipids Health Dis Date: 2017-10-16 Impact factor: 3.876