Abstract
The purpose of the present study was designed to evaluate the bioequivalence of two benidipine hydrochloride tablets, Codipine (Youngjin Pharm. Co., Ltd.) and Benipine (Myungmoon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.00{\pm}1.82$ year in age and $70.08{\pm}9.59$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 4 mg of benidipine hydrochloride were orally administered, blood was taken at predetermined time intervals and concentrations of benidipine in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, and $C_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 $(e.g., \;log1.04{\sim}log1.24\;and\;log0.91{\sim}log1.09$ for $AUC_t$, and $C_{max}$ respectively). The major parameters, $AUC_t$ and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Benipine tablet is bioequivalent to Codipine tablet.
