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KMID : 0941820010110010007
Korean Journal of Clinical Pharmacy
2001 Volume.11 No. 1 p.7 ~ p.12
Bioequivalence of LG Cilostazol Tablet to Pletaal Tablet (Cilostazol 100 mg)
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Abstract
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 Pletaal^{TM} (Korea Otsuka Pharmaceutical Co.) and the LG Cilostazol^{TM} (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers (20sim29 years old) were randomly divided into two groups and a randomized 2times2 cross-over study was employed. After oral administration of Pletaal^{TM} or LG Cilostazol^{TM} 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 (AUC_t,;C_{max};and;T_{max}) 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 Pletaal^{TM} tablet were -5.39%,;2.32%;and;4.26%, respectively. The powers (1-{beta}) for AUC_t,;C_{max};and;T_{max};were;83.81%,;96.02%;and;91.04%, respectively. Minimum detectable differences (Delta) and 90% confidence intervals were all less than pm20%. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG Cilostazol^{TM} tablet is bioequivalent to Pletaal^{TM} tablet.
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