TITLE

Effect of food on the single-dose pharmacokinetics and tolerability of dalfampridine extended-release tablets in healthy volunteers

AUTHOR(S)
HENNEY III, HERBERT R.; FAUST, BONNIE; BLIGHT, ANDREW R.
PUB. DATE
November 2011
SOURCE
American Journal of Health-System Pharmacy;11/15/2011, Vol. 68 Issue 22, p2148
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Purpose. 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 (Cmax) and areas under the plasma-concentration curve (AUC) for 24- hour exposure (AUC0-24) and total exposure (AUC0-∞). 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 Cmax 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. Conclusion. When a single 10-mg dose of dalfampridine was given to healthy volunteers after a high-fat meal, a significant increase in Cmax 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.
ACCESSION #
67225536

 

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