Document Detail

The effect of food on the bioavailability of dolasetron mesylate tablets.
MedLine Citation:
PMID:  9510981     Owner:  NLM     Status:  MEDLINE    
Anzemet (dolasetron mesylate) is being developed for the prevention of chemotherapy-induced emesis and postoperative nausea and vomiting. Twenty-four healthy male subjects were orally dosed with dolasetron mesylate, 200 mg, after either an overnight fast or a high-fat breakfast. The ratio of the mean area under the plasma concentration-time curve of the reduced active metabolite (MDL 74,156) to infinity (AUC(0-infinity)) values in fed compared to fasting subjects was 86.3% with a 90% confidence interval for the ratio within (80, 125)%, indicating bioequivalence. The ratio of the mean MDL 74,156 maximum plasma concentration (Cmax) values was 70.6% in fed versus fasted subjects. The time to Cmax was statistically significantly longer after the high-fat breakfast (mean values, 1.11 h fasting and 1.80 h fed), probably due to delayed gastric emptying. It may be concluded that, although the rate of absorption was somewhat delayed, the extent of absorption did not change significantly when dolasetron mesylate was given with food.
C Lippert; A Keung; T Arumugham; M Eller; W Hahne; S Weir
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Biopharmaceutics & drug disposition     Volume:  19     ISSN:  0142-2782     ISO Abbreviation:  Biopharm Drug Dispos     Publication Date:  1998 Jan 
Date Detail:
Created Date:  1998-04-23     Completed Date:  1998-04-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7911226     Medline TA:  Biopharm Drug Dispos     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  17-9     Citation Subset:  IM    
Pharmacokinetics Department, Hoechst Marion Roussel, Inc., Kansas City, MO 64134-0627, USA.
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MeSH Terms
Area Under Curve
Biological Availability
Chromatography, Liquid
Cross-Over Studies
Fasting / metabolism
Food-Drug Interactions*
Indoles / pharmacokinetics*
Mass Spectrometry
Quinolizines / pharmacokinetics*
Serotonin Antagonists / pharmacokinetics*
Reg. No./Substance:
0/Indoles; 0/Quinolizines; 0/Serotonin Antagonists; 0/Tablets; 115956-13-3/dolasetron mesylate

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

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