title: Limited effect of food composition on the pharmacokinetics of nelfinavir administered twice daily.
abstract: The objective of the study was to investigate the effect of two different breakfasts on the pharmacokinetics of nelfinavir under steady state conditions.
  
  
  METHODS
  Twenty-four healthy male volunteers were evaluated in a 17 days open labeled one sequence crossover study evaluating the effect of a 'light' breakfast (350 kcal) compared to a standard breakfast (800 kcal) on the pharmacokinetics of nelfinavir at steady state during 1250 mg twice daily (BID) administration.
  
  
  RESULTS
  After administration with a standard breakfast higher concentrations of nelfinavir were observed during the terminal phase than after administration with a 'light' breakfast. The comparison of the log subset 10 transformed parameters C subset 1-hr-postdose, AUC subset 0-12h, C subset max, and C subset 12 hours, showed that the AUC subset 0-12h was decreased by 13% (P = 0.01) after administration with the 'light' breakfast. Nelfinavir 1250 mg BID was well tolerated.
  
  
  CONCLUSIONS
  Although drug intake with a 'light' breakfast' showed a statistically significant decrease for nelfinavir AUC subset 0-12h, this marginal 13% reduction is not considered clinically relevant. No significant effects of the two different breakfasts were found for the remaining three parameters tested C subset 1-hr-postdose, C subset max, and C subset 12 hours.
authors.affiliation: Therapia GmbH, c/o Auguste Viktoria Krankenhaus, Immunologische Tagesklinik, Rubensstr. 125, 12157 Berlin, Germany. Labor-Kurowski@t-online.de
authors.forename: Michael
authors.initials: M
authors.lastname: Kurowski
authors.forename: B
authors.initials: B
authors.lastname: Kaeser
authors.forename: A
authors.initials: A
authors.lastname: Sawyer
authors.forename: M
authors.initials: M
authors.lastname: Popescu
authors.forename: A
authors.initials: A
authors.lastname: Mroziekiewicz
authors.forename: A
authors.initials: A
authors.lastname: Arslan
authors.forename: S
authors.initials: S
authors.lastname: Staszewski
mesh_terms: D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D018565:Food-Drug Interactions; D006801:Humans; D019888:Nelfinavir / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012016:Reference Values; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*
chemical_list: D018894:Reverse Transcriptase Inhibitors; D019888:Nelfinavir