title: Effect of food on the single-dose pharmacokinetics and tolerability of dalfampridine extended-release tablets in healthy volunteers.
abstract: OBJECTIVE
  The pharmacokinetics, bioavailability, and tolerability of dalfampridine extended-release tablets in healthy adults under fed and fasted conditions were evaluated.
  
  
  METHODS
  The study participants (n = 30) were randomly assigned to receive one 10-mg dalfampridine tablet in a fasted condition (no food for 10-12 hours) or a fed condition (after a high-fat meal); after a seven-day washout period, participants received the same dalfampridine dosage under the converse condition. The endpoints were the maximum plasma drug concentration (C(max)) and areas under the plasma-concentration curve (AUC) for 24-hour exposure (AUC(0-24)) and total exposure (AUC(0-∞)). A 90% two-sided confidence interval (CI) within predefined limits for the fed:fasted ratio of the geometric mean values was used as the standard for determining the absence of a significant food effect.
  
  
  RESULTS
  Among the participants who received both treatments (n = 28), food intake was associated with a 23% increase in the log-transformed geometric mean C(max) of dalfampridine (p ≤ 0.10) but no significant change in mean AUC values. Eight (26.7%) of the study participants reported a total of 13 adverse events (AEs), of which only dizziness and upper abdominal pain occurred in more than one participant; all AEs were of mild-to-moderate severity.
  
  
  CONCLUSIONS
  When a single 10-mg dose of dalfampridine was given to healthy volunteers after a high-fat meal, a significant increase in C(max) was observed. However, overall differences in dalfampridine pharmacokinetics when the drug was administered to participants under fasting and fed conditions did not exceed predefined limits, indicating that the extended-release formulation may be taken without regard to meals.
authors: Acorda Therapeutics, Inc., 15 Skyline Drive, Hawthorne, NY 10532, USA. henney@acorda.com
authors: Herbert R
authors: HR
authors: Henney
authors: Bonnie
authors: B
authors: Faust
authors: Andrew R
authors: AR
authors: Blight
mesh_terms: D015761:4-Aminopyridine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D001682:Biological Availability; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005215:Fasting / Q000502:physiology; D005260:Female; D018565:Food-Drug Interactions; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D026902:Potassium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D011446:Prospective Studies; D012737:Sex Factors; D016138:Walking / Q000502:physiology; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D026902:Potassium Channel Blockers; D015761:4-Aminopyridine