Document Detail


Comparative analysis of the effects of rice and bread meals on bioavailability of itraconazole using NONMEM in healthy volunteers.
MedLine Citation:
PMID:  17053894     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The objectives of this retrospective study were to examine the relationship between the bioavailability of itraconazole and the type of food consumed and to determine the effects of food consumption on the pharmacokinetic parameters following a single oral dose of itraconazole in healthy volunteers. METHODS: The plasma itraconazole concentration-time data were pooled from four pharmacokinetic studies in 144 healthy subjects. Individual pharmacokinetic values were estimated as model-independent (AUC, C (max), and T (max)) and model-dependent (T (lag), K (a), K (cp), K (pc), K (el), and V (d)/F; two-compartment open model with lag time) parameters using the WinNonlin software program. We estimated the population characteristics of the food effects using NONMEM. RESULTS: The consumption of a bread meal before the administration of itraconazole caused a significant increase in its bioavailability, as well as increases in the peak plasma concentration and lag time for itraconazole absorption. On the contrary, consumption of a rice meal before the administration of itraconazole caused a significant decrease in its bioavailability. CONCLUSION: Therefore, although a dose of itraconazole is normally administered immediately after a meal to increase its bioavailability, this is not an effective strategy after a rice meal.
Authors:
Hwi-yeol Yun; Min Sun Baek; In Sook Park; Bo Kyung Choi; Kwang-il Kwon
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-10-20
Journal Detail:
Title:  European journal of clinical pharmacology     Volume:  62     ISSN:  0031-6970     ISO Abbreviation:  Eur. J. Clin. Pharmacol.     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2006-11-19     Completed Date:  2007-12-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1256165     Medline TA:  Eur J Clin Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  1033-9     Citation Subset:  IM    
Affiliation:
College of Pharmacy, Chungnam National University, Daejeon 305-764, South Korea.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Algorithms
Analysis of Variance
Antifungal Agents / administration & dosage,  blood,  pharmacokinetics
Area Under Curve
Biological Availability
Bread*
Capsules
Chromatography, High Pressure Liquid / methods
Cluster Analysis
Cross-Over Studies
Dose-Response Relationship, Drug
Eating / physiology*
Female
Food-Drug Interactions
Humans
Itraconazole / administration & dosage,  blood,  pharmacokinetics*
Male
Oryza sativa*
Retrospective Studies
Software*
Time Factors
Chemical
Reg. No./Substance:
0/Antifungal Agents; 0/Capsules; 84625-61-6/Itraconazole

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


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