title: Comparative Fasting Bioavailability of 2 Cilostazol Formulations in Healthy Thai Volunteers: An Open-Label, Single-Dose, Randomized, 2-Way Crossover Study.
abstract: OBJECTIVE
  To evaluate the bioequivalence of50 mg cilostazol tablets manufactured locally (Citazol®) and originally (Pletaal®) in healthy Thai volunteers.
  
  
  METHODS
  An open-label, single dose, randomized, two-period, two-sequence, crossover study in 30 healthy volunteers. Each volunteer received a 50 mg cilostazol tablet of bothformulations with a washoutperiodofat least 14 days. Blood samples were obtained atpre-dose and over 48 hours after dosing. Cilostazolplasma concentrations were quantified by using liquid chromatography with tandem mass spectrometry (LC-MS/MS).
  
  
  RESULTS
  The 30 volunteers completed the entire study. The geometric mean ratios (GAM) (test/reference) between the two formulations of cilostazol were 112.38% (101.70%-124.19%) for Cmax; 103.66% (96.06%-111.86%) for AUC0-48; and 95.14% (86.12%-105.12%)forAUC0-∞. There was no statistical difference ofthe Tmax between the twoformulations (p>0.05). No serious adverse events related to the studied drugs were found.
  
  
  CONCLUSIONS
  No significant difference in the analyzed pharmacokineticparameters was found between the twoformulations of 50 mg cilostazol tablets. Therefore, it can be concluded that these two cilostazol tablet formulations were considered bioequivalent.
authors.forename: Pinpilai
authors.initials: P
authors.lastname: Jutasompakorn
authors.forename: Supornchai
authors.initials: S
authors.lastname: Kongpatanakul
authors.forename: Piyapat
authors.initials: P
authors.lastname: Pongnarin
authors.forename: Korbtham
authors.initials: K
authors.lastname: Sathirakul
authors.forename: Somruedee
authors.initials: S
authors.lastname: Chatsiricharoenkul
mesh_terms: D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D000077407:Cilostazol; D018592:Cross-Over Studies; D005215:Fasting; D058987:Phosphodiesterase 3 Inhibitors / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry; D013777:Tetrazoles / Q000493:pharmacokinetics*; D013785:Thailand; D013810:Therapeutic Equivalency
chemical_list: D058987:Phosphodiesterase 3 Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol