Document Detail


Influence of food intake on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase.
MedLine Citation:
PMID:  17720777     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objective of this study was to investigate the effect of food on the pharmacokinetics of miglustat, an inhibitor of glucosylceramide synthase. Twenty-four healthy male (n = 9) and female (n = 15) subjects were treated in a randomized, 2-way crossover design with a single oral dose of 100 mg miglustat with or without food. Consumption of a standard high-fat breakfast within 30 minutes before administration of miglustat significantly reduced peak exposure but did not significantly affect the extent of systemic exposure to miglustat. The peak plasma concentration (C(max)) decreased by 36% on average following administration with food. Area under the plasma concentration-time curve (AUC(0-infinity)) showed a modest (14%) decrease with food, but the 90% confidence interval was within the acceptance limit of 80% to 125%. The median (min-max) time to C(max) (t(max)) was prolonged from 2.5 (1.0-4.0) hours in the fasted state to 4.5 (1.5-8.0) hours in the fed state, whereas the apparent terminal half-life was approximately 8 hours and not affected by food. In conclusion, the intake of food has an effect on some pharmacokinetic parameters such as C(max) and t(max) but does not affect the extent of exposure to miglustat. The observed effects of food intake on the pharmacokinetics of miglustat are not considered to be of clinical relevance.
Authors:
Paul L M van Giersbergen; Jasper Dingemanse
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-08-24
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  47     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-01     Completed Date:  2007-12-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1277-82     Citation Subset:  IM    
Affiliation:
Actelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Gewerbestrasse 16, 4123 Allschwil, Switzerland. paul.vangiersbergen@actelion.com
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MeSH Terms
Descriptor/Qualifier:
1-Deoxynojirimycin / administration & dosage,  analogs & derivatives*,  blood,  pharmacokinetics
Adolescent
Adult
Area Under Curve
Cross-Over Studies
Female
Food-Drug Interactions*
Glucosyltransferases / antagonists & inhibitors*
Half-Life
Humans
Male
Middle Aged
Sex Factors
Chemical
Reg. No./Substance:
0/miglustat; 19130-96-2/1-Deoxynojirimycin; EC 2.4.1.-/Glucosyltransferases; EC 2.4.1.80/ceramide glucosyltransferase

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


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