Document Detail


Effect of food on the single-dose pharmacokinetics and tolerability of dalfampridine extended-release tablets in healthy volunteers.
MedLine Citation:
PMID:  22058101     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 (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.
CONCLUSION: 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:
Herbert R Henney; Bonnie Faust; Andrew R Blight
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists     Volume:  68     ISSN:  1535-2900     ISO Abbreviation:  Am J Health Syst Pharm     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-07     Completed Date:  2012-02-28     Revised Date:  2012-06-05    
Medline Journal Info:
Nlm Unique ID:  9503023     Medline TA:  Am J Health Syst Pharm     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2148-54     Citation Subset:  IM    
Affiliation:
Acorda Therapeutics, Inc., 15 Skyline Drive, Hawthorne, NY 10532, USA. henney@acorda.com
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MeSH Terms
Descriptor/Qualifier:
4-Aminopyridine / administration & dosage,  adverse effects,  pharmacokinetics*
Adolescent
Adult
Analysis of Variance
Biological Availability
Cross-Over Studies
Delayed-Action Preparations
Fasting / physiology
Female
Food-Drug Interactions*
Humans
Male
Middle Aged
Multiple Sclerosis / drug therapy*
Potassium Channel Blockers / administration & dosage,  adverse effects,  pharmacokinetics
Prospective Studies
Sex Factors
Walking / physiology
Young Adult
Chemical
Reg. No./Substance:
0/Delayed-Action Preparations; 0/Potassium Channel Blockers; 504-24-5/4-Aminopyridine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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