earticle

영어

Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the (Korea Otsuka Pharmaceutical Co.) and the LG (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ( years old) were randomly divided into two groups and a randomized cross-over study was employed. After oral administration of or LG tablet (100 mg cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUCt, C_{max} and Tmax between two tablets based on the tablet were , respectively. The powers (1-) for , respectively. Minimum detectable differences () and confidence intervals were all less than . All these parameters met the criteria of KFDA for bioequivalence, indicating that LG tablet is bioequivalent to tablet.