FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2137487029> ?p ?o ?g. }

• W2137487029 endingPage "1563" @default.
• W2137487029 startingPage "1555" @default.
• W2137487029 abstract "Amifampridine (3,4-diaminopyridine) has been approved in the European Union for the treatment of Lambert-Eaton myasthenic syndrome. Amifampridine has a narrow therapeutic index, and supratherapeutic exposure has been associated with dose-dependent adverse events, including an increased risk for seizure. This study assessed the effect of food on the relative bioavailability of amifampridine in healthy subjects and informed on conditions that can alter exposure.This randomized, open-labeled, 2-treatment, 2-period crossover study enrolled 47 healthy male and female subjects. Subjects were randomly assigned to receive 2 single oral doses of amifampridine phosphate salt (20 mg base equivalents per dose) under fed or fasted conditions separated by a washout period. Blood and urine samples for pharmacokinetic analyses were taken before and after dosing. Plasma concentrations of amifampridine and an inactive 3-N-acetyl metabolite were determined. The relative bioavailability values of amifampridine and metabolite were assessed based on the plasma PK parameters AUC0-∞, AUC0-t, and Cmax in the fed and fasted states using noncompartmental pharmacokinetic analysis. Parent drug and metabolite excretion were calculated from urinary concentrations. A food effect on bioavailability would be established if the 90% CI of the ratio of population geometric mean value of AUC0-∞, AUC0-t, or Cmax between fed and fasted administration was not within the bioequivalence range of 80% to 125%. Tolerability was assessed based on adverse-event reporting, clinical laboratory assessments, physical examination including vital sign measurements, 12-lead ECG, and concurrent medication use.Food slowed and somewhat decreased the absorption of amifampridine. There was a decrease in exposure (Cmax, 44%; AUC, 20%) after oral administration of amifampridine phosphate salt in the presence of food, and mean Tmax was 2-fold longer in the fed state. The extent of exposure and plasma elimination half-life of the major metabolite was greater than those of amifampridine in the fed and fasted conditions. Mean AUCs in the fed and fasted states were slightly greater in women than men, with no difference in mean Cmax. Orally administered amifampridine was renally eliminated (>93%) as the parent compound and metabolite within 24 hours. Single oral doses of 20 mg of amifampridine phosphate salt were considered well tolerated in both the fed and fasted conditions. High intersubject variability (%CVs, >30%) in amifampridine pharmacokinetic parameter values was observed.At the intended dose under fasting conditions, amifampridine exposure may be increased. European Union Drug Regulating Authorities Clinical Trials identifier: 2011-000596-13." @default.
• W2137487029 created "2016-06-24" @default.
• W2137487029 creator A5023350591 @default.
• W2137487029 creator A5032921714 @default.
• W2137487029 creator A5040703282 @default.
• W2137487029 creator A5074832186 @default.
• W2137487029 creator A5089925289 @default.
• W2137487029 date "2015-07-01" @default.
• W2137487029 modified "2023-10-14" @default.
• W2137487029 title "Effects of Food Intake on the Relative Bioavailability of Amifampridine Phosphate Salt in Healthy Adults" @default.
• W2137487029 cites W1585470061 @default.
• W2137487029 cites W1969187588 @default.
• W2137487029 cites W1973029867 @default.
• W2137487029 cites W1987418443 @default.
• W2137487029 cites W2022305432 @default.
• W2137487029 cites W2023879879 @default.
• W2137487029 cites W2039231120 @default.
• W2137487029 cites W2062369227 @default.
• W2137487029 cites W2148018737 @default.
• W2137487029 cites W4246094258 @default.
• W2137487029 doi "https://doi.org/10.1016/j.clinthera.2015.05.498" @default.
• W2137487029 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/26101174" @default.
• W2137487029 hasPublicationYear "2015" @default.
• W2137487029 type Work @default.
• W2137487029 sameAs 2137487029 @default.
• W2137487029 citedByCount "8" @default.
• W2137487029 countsByYear W21374870292017 @default.
• W2137487029 countsByYear W21374870292018 @default.
• W2137487029 countsByYear W21374870292019 @default.
• W2137487029 countsByYear W21374870292021 @default.
• W2137487029 countsByYear W21374870292023 @default.
• W2137487029 crossrefType "journal-article" @default.
• W2137487029 hasAuthorship W2137487029A5023350591 @default.
• W2137487029 hasAuthorship W2137487029A5032921714 @default.
• W2137487029 hasAuthorship W2137487029A5040703282 @default.
• W2137487029 hasAuthorship W2137487029A5074832186 @default.
• W2137487029 hasAuthorship W2137487029A5089925289 @default.
• W2137487029 hasBestOaLocation W21374870291 @default.
• W2137487029 hasConcept C112705442 @default.
• W2137487029 hasConcept C126322002 @default.
• W2137487029 hasConcept C142724271 @default.
• W2137487029 hasConcept C181389837 @default.
• W2137487029 hasConcept C197934379 @default.
• W2137487029 hasConcept C204787440 @default.
• W2137487029 hasConcept C22979827 @default.
• W2137487029 hasConcept C27081682 @default.
• W2137487029 hasConcept C2777288759 @default.
• W2137487029 hasConcept C2777477808 @default.
• W2137487029 hasConcept C2778375690 @default.
• W2137487029 hasConcept C2780026642 @default.
• W2137487029 hasConcept C2908647359 @default.
• W2137487029 hasConcept C42404028 @default.
• W2137487029 hasConcept C71924100 @default.
• W2137487029 hasConcept C87813604 @default.
• W2137487029 hasConcept C98274493 @default.
• W2137487029 hasConcept C99454951 @default.
• W2137487029 hasConceptScore W2137487029C112705442 @default.
• W2137487029 hasConceptScore W2137487029C126322002 @default.
• W2137487029 hasConceptScore W2137487029C142724271 @default.
• W2137487029 hasConceptScore W2137487029C181389837 @default.
• W2137487029 hasConceptScore W2137487029C197934379 @default.
• W2137487029 hasConceptScore W2137487029C204787440 @default.
• W2137487029 hasConceptScore W2137487029C22979827 @default.
• W2137487029 hasConceptScore W2137487029C27081682 @default.
• W2137487029 hasConceptScore W2137487029C2777288759 @default.
• W2137487029 hasConceptScore W2137487029C2777477808 @default.
• W2137487029 hasConceptScore W2137487029C2778375690 @default.
• W2137487029 hasConceptScore W2137487029C2780026642 @default.
• W2137487029 hasConceptScore W2137487029C2908647359 @default.
• W2137487029 hasConceptScore W2137487029C42404028 @default.
• W2137487029 hasConceptScore W2137487029C71924100 @default.
• W2137487029 hasConceptScore W2137487029C87813604 @default.
• W2137487029 hasConceptScore W2137487029C98274493 @default.
• W2137487029 hasConceptScore W2137487029C99454951 @default.
• W2137487029 hasIssue "7" @default.
• W2137487029 hasLocation W21374870291 @default.
• W2137487029 hasLocation W21374870292 @default.
• W2137487029 hasOpenAccess W2137487029 @default.
• W2137487029 hasPrimaryLocation W21374870291 @default.
• W2137487029 hasRelatedWork W2011337719 @default.
• W2137487029 hasRelatedWork W2349338867 @default.
• W2137487029 hasRelatedWork W2351154051 @default.
• W2137487029 hasRelatedWork W2356698425 @default.
• W2137487029 hasRelatedWork W2357220270 @default.
• W2137487029 hasRelatedWork W2359939078 @default.
• W2137487029 hasRelatedWork W2364471871 @default.
• W2137487029 hasRelatedWork W2374069256 @default.
• W2137487029 hasRelatedWork W2381431760 @default.
• W2137487029 hasRelatedWork W3146022116 @default.
• W2137487029 hasVolume "37" @default.
• W2137487029 isParatext "false" @default.
• W2137487029 isRetracted "false" @default.
• W2137487029 magId "2137487029" @default.
• W2137487029 workType "article" @default.