Matches in SemOpenAlex for { <https://semopenalex.org/work/W3207564110> ?p ?o ?g. }
- W3207564110 endingPage "79" @default.
- W3207564110 startingPage "69" @default.
- W3207564110 abstract "Viloxazine extended-release (viloxazine ER) capsules (QelbreeTM) is a novel nonstimulant recently approved as a treatment for attention-deficit/hyperactivity disorder in children and adolescents. Here, we determined whether the pharmacokinetics of viloxazine are impacted by consuming the capsule contents sprinkled on applesauce rather than an intact capsule, and the effect of a high-fat meal on the pharmacokinetics of viloxazine ER. This was a randomized, open-label, crossover, three-treatment, three-period study in healthy adults using orally administered single-dose viloxazine ER 200 mg capsules. Subjects consumed: (1) an intact capsule after a 10-h fast (control condition); (2) the capsule contents sprinkled on one tablespoon of applesauce; and (3) an intact capsule with a standard high-fat meal. Blood samples were collected for 48 h post-dosing. Relative bioavailability analyses were performed to assess the impact of each test condition against the control condition (intact capsule, fasting). The absence of an impact was indicated if the 90% confidence interval (CI) for the least-squares geometric mean ratio (LSGMR) of maximal concentration (Cmax), the area under the concentration–time curve from time 0 to the last measurable concentration time (AUClast), and the area under the concentration–time curve from time 0 to infinity (AUCinf) were within the predetermined no-difference limits of 80–125%. Out of 27 enrolled subjects, 25 were included in the pharmacokinetic analysis. The LSGMR (90% CI) for viloxazine ER sprinkled vs. intact were 90.10% (83.35–97.40) for Cmax, 93.71% (89.09–98.57) for AUClast, and 95.37% (89.80–101.28) for AUCinf. The LSGMR (90% CI) for viloxazine ER consumed in the fed state vs. fasting state were 90.86% (84.05–98.21) for Cmax, 89.68% (85.26–94.33) for AUClast, and 92.35% (86.96–98.07) for AUCinf. The 90% CIs of the LSGMRs were within the predetermined no-difference limits of 80–125%. Viloxazine ER was well tolerated, with most adverse events reported as mild. These data suggest that viloxazine ER can be consumed sprinkled on applesauce or as intact capsules with or without meals without significantly changing its pharmacokinetics." @default.
- W3207564110 created "2021-10-25" @default.
- W3207564110 creator A5008347684 @default.
- W3207564110 creator A5034593787 @default.
- W3207564110 creator A5036952053 @default.
- W3207564110 creator A5065963598 @default.
- W3207564110 creator A5072097629 @default.
- W3207564110 creator A5072640106 @default.
- W3207564110 creator A5076457631 @default.
- W3207564110 date "2021-10-15" @default.
- W3207564110 modified "2023-10-18" @default.
- W3207564110 title "Impact of a High-Fat Meal and Sprinkled Administration on the Bioavailability and Pharmacokinetics of Viloxazine Extended-Release Capsules (QelbreeTM) in Healthy Adult Subjects" @default.
- W3207564110 cites W152508709 @default.
- W3207564110 cites W15348943 @default.
- W3207564110 cites W1551616392 @default.
- W3207564110 cites W1653311125 @default.
- W3207564110 cites W1965649599 @default.
- W3207564110 cites W1974490747 @default.
- W3207564110 cites W1998133178 @default.
- W3207564110 cites W1999306596 @default.
- W3207564110 cites W2000187301 @default.
- W3207564110 cites W2002482892 @default.
- W3207564110 cites W2006058627 @default.
- W3207564110 cites W202305576 @default.
- W3207564110 cites W2024190072 @default.
- W3207564110 cites W2028371970 @default.
- W3207564110 cites W2048588916 @default.
- W3207564110 cites W2065450031 @default.
- W3207564110 cites W2083731774 @default.
- W3207564110 cites W2084339881 @default.
- W3207564110 cites W2102388069 @default.
- W3207564110 cites W2104076875 @default.
- W3207564110 cites W2118636292 @default.
- W3207564110 cites W2138292251 @default.
- W3207564110 cites W2141378806 @default.
- W3207564110 cites W2159881136 @default.
- W3207564110 cites W2415530268 @default.
- W3207564110 cites W2611883897 @default.
- W3207564110 cites W2724395843 @default.
- W3207564110 cites W2789958560 @default.
- W3207564110 cites W2962626783 @default.
- W3207564110 cites W3025751746 @default.
- W3207564110 cites W3045331755 @default.
- W3207564110 cites W3113602892 @default.
- W3207564110 cites W3129861271 @default.
- W3207564110 cites W3135453045 @default.
- W3207564110 cites W3157482248 @default.
- W3207564110 cites W3162116659 @default.
- W3207564110 cites W3170851891 @default.
- W3207564110 cites W3182735813 @default.
- W3207564110 cites W4236486344 @default.
- W3207564110 cites W4247665917 @default.
- W3207564110 cites W4287268235 @default.
- W3207564110 doi "https://doi.org/10.1007/s13318-021-00729-6" @default.
- W3207564110 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34652564" @default.
- W3207564110 hasPublicationYear "2021" @default.
- W3207564110 type Work @default.
- W3207564110 sameAs 3207564110 @default.
- W3207564110 citedByCount "3" @default.
- W3207564110 countsByYear W32075641102022 @default.
- W3207564110 crossrefType "journal-article" @default.
- W3207564110 hasAuthorship W3207564110A5008347684 @default.
- W3207564110 hasAuthorship W3207564110A5034593787 @default.
- W3207564110 hasAuthorship W3207564110A5036952053 @default.
- W3207564110 hasAuthorship W3207564110A5065963598 @default.
- W3207564110 hasAuthorship W3207564110A5072097629 @default.
- W3207564110 hasAuthorship W3207564110A5072640106 @default.
- W3207564110 hasAuthorship W3207564110A5076457631 @default.
- W3207564110 hasBestOaLocation W32075641101 @default.
- W3207564110 hasConcept C112705442 @default.
- W3207564110 hasConcept C126322002 @default.
- W3207564110 hasConcept C142724271 @default.
- W3207564110 hasConcept C181389837 @default.
- W3207564110 hasConcept C204787440 @default.
- W3207564110 hasConcept C22979827 @default.
- W3207564110 hasConcept C27081682 @default.
- W3207564110 hasConcept C2778345441 @default.
- W3207564110 hasConcept C2778778583 @default.
- W3207564110 hasConcept C59822182 @default.
- W3207564110 hasConcept C71924100 @default.
- W3207564110 hasConcept C76318530 @default.
- W3207564110 hasConcept C86803240 @default.
- W3207564110 hasConcept C87813604 @default.
- W3207564110 hasConcept C98274493 @default.
- W3207564110 hasConceptScore W3207564110C112705442 @default.
- W3207564110 hasConceptScore W3207564110C126322002 @default.
- W3207564110 hasConceptScore W3207564110C142724271 @default.
- W3207564110 hasConceptScore W3207564110C181389837 @default.
- W3207564110 hasConceptScore W3207564110C204787440 @default.
- W3207564110 hasConceptScore W3207564110C22979827 @default.
- W3207564110 hasConceptScore W3207564110C27081682 @default.
- W3207564110 hasConceptScore W3207564110C2778345441 @default.
- W3207564110 hasConceptScore W3207564110C2778778583 @default.
- W3207564110 hasConceptScore W3207564110C59822182 @default.
- W3207564110 hasConceptScore W3207564110C71924100 @default.
- W3207564110 hasConceptScore W3207564110C76318530 @default.
- W3207564110 hasConceptScore W3207564110C86803240 @default.
- W3207564110 hasConceptScore W3207564110C87813604 @default.