title: Comparative analysis of the effects of rice and bread meals on bioavailability of itraconazole using NONMEM in healthy volunteers.
abstract: 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.
  
  
  CONCLUSIONS
  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.affiliation: College of Pharmacy, Chungnam National University, Daejeon 305-764, South Korea.
authors.forename: Hwi-yeol
authors.initials: HY
authors.lastname: Yun
authors.forename: Min Sun
authors.initials: MS
authors.lastname: Baek
authors.forename: In Sook
authors.initials: IS
authors.lastname: Park
authors.forename: Bo Kyung
authors.initials: BK
authors.lastname: Choi
authors.forename: Kwang-il
authors.initials: KI
authors.lastname: Kwon
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000465:Algorithms; D000704:Analysis of Variance; D000935:Antifungal Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D019540:Area Under Curve; D001682:Biological Availability; D001939:Bread; D002214:Capsules; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D016000:Cluster Analysis; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000502:physiology*; D005260:Female; D018565:Food-Drug Interactions; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D012275:Oryza; D012189:Retrospective Studies; D012984:Software; D013997:Time Factors
chemical_list: D000935:Antifungal Agents; D002214:Capsules; D017964:Itraconazole