Comparative fasting bioavailability of 2 cilostazol formulations in healthy Thai volunteers: An open-label, single-dose, randomized, 2-way crossover study

Abstract

© 2015, Medical Association of Thailand. All Rights reserved. Objective: To evaluate the bioequivalence of 50 mg cilostazol tablets manufactured locally (Citazol®) and originally (Pletaal®) in healthy Thai volunteers. Material and Method: 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 both formulations with a washout period of at least 14 days. Blood samples were obtained at pre-dose and over 48 hours after dosing. Cilostazol plasma 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 (GMR) (test/reference) between the two formulations of cilostazol were 112.38% (101.70%-124.19%) for C<inf>max</inf>; 103.66% (96.06%-111.86%) for AUC<inf>0-48</inf>; and 95.14% (86.12%-105.12%) for AUC<inf>0-8</inf>. There was no statistical difference of the T<inf>max</inf> between the two formulations (p>0.05). No serious adverse events related to the studied drugs were found. Conclusion: No significant difference in the analyzed pharmacokinetic parameters was found between the two formulations of 50 mg cilostazol tablets. Therefore, it can be concluded that these two cilostazol tablet formulations were considered bioequivalent.