title: Effect of food on the pharmacokinetics of triflusal and its major active metabolite, 2-hydroxy-4-trifluoromethyl benzoic acid, in healthy subjects.
abstract: OBJECTIVE
  The objective of this study was to evaluate the pharmacokinetic parameters of triflusal and its major active metabolite, 2-hydroxy-4-trifluoromethyl benzoic acid (HTB), following a single oral dose of 900 mg in healthy subjects under fed and fasting conditions.
  
  
  METHODS
  The study participants (n=12) were randomized to receive one 900 mg triflusal capsule in a fasting condition (no food for 12 hours) or a fed condition (after a high-fat meal); after a 2-week washout period, participants received the same dose of triflusal capsule under the converse condition. Pharmacokinetic parameters were calculated using WinNonlin 6.2 software. Safety was evaluated through assessment of adverse events, standard laboratory evaluations, vital signs, and 12-lead electrocardiography.
  
  
  RESULTS
  The mean Cmax of triflusal and HTB were 13.96, 110.2 ug/mL for the fasting state and 9.546, 97.15 ug/mL for the fed state, respectively. The AUC0-144 of triflusal and HTB were 19.66, 5,572 hxμg/mL for the fasting state and 22.20, 5,038 hxμg/mL for the fed state, the AUC0-∞ of triflusal and HTB were 19.79, 6,333 hxμg/mL for the fasting state and 22.44, 5,632 hxμg/mL for the fed state, respectively. The results showed that Cmax and AUCs for triflusal were outside the bioequivalency (BE) interval after food intake, but there was no statistically significant change for HTB.
  
  
  CONCLUSIONS
  High-fat food intake may affect the pharmacokinetics of triflusal capsule in healthy subjects.
authors.forename: Jie
authors.initials: J
authors.lastname: Ge
authors.forename: Li-Kun
authors.initials: LK
authors.lastname: Ding
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.forename: Yan-yan
authors.initials: YY
authors.lastname: Jia
authors.forename: Cheng-tao
authors.initials: CT
authors.lastname: Lu
authors.forename: Yi
authors.initials: Y
authors.lastname: Ding
authors.forename: Ying
authors.initials: Y
authors.lastname: Song
authors.forename: Wei
authors.initials: W
authors.lastname: Song
authors.forename: Ai-dong
authors.initials: AD
authors.lastname: Wen
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001711:Biotransformation; D002214:Capsules; D002681:China; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000008:administration & dosage; D005215:Fasting / Q000097:blood; D005260:Female; D018565:Food-Drug Interactions; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D008954:Models, Biological; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019518:Postprandial Period; D012459:Salicylates / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D002214:Capsules; D004041:Dietary Fats; D010975:Platelet Aggregation Inhibitors; D012459:Salicylates; C016167:triflusal; C033502:4-trifluoromethylsalicylic acid