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Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling.
Pepin XJH, Hynes SM, Zahir H, Walker D, Semmens LQ, Suarez-Sharp S. Pepin XJH, et al. CPT Pharmacometrics Syst Pharmacol. 2024 Oct;13(10):1771-1783. doi: 10.1002/psp4.13221. Epub 2024 Sep 2. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 39219492 Free PMC article.
The effect of the US Food and Drug Administration (FDA) high-fat breakfast on the pharmacokinetic profile of omaveloxolone observed in study 408-C-1703 (NCT03664453) deviated from the usual linear correlation between fed/fasted maximum plasma concentration (C(max)) and area under …
The effect of the US Food and Drug Administration (FDA) high-fat breakfast on the pharmacokinetic profile of omaveloxolone observed in study …
Relative Bioavailability of Omaveloxolone When Capsules Are Sprinkled Over and Mixed in Applesauce Compared With Administration as Intact Omaveloxolone Capsules: A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study in Healthy Adults.
Hynes SM, Goldsberry A, Henneghan PD, Murai M, Shinde A, Wells JA, Wu L, Wu T, Zahir H, Khan S. Hynes SM, et al. J Clin Pharmacol. 2024 Oct;64(10):1304-1311. doi: 10.1002/jcph.2482. Epub 2024 Jun 4. J Clin Pharmacol. 2024. PMID: 38837775 Clinical Trial.