Bioequivalence of A-PINE Tablet to SKAD Tablet (Amlodipine Maleate 6.42 mg)

The purpose of this study was to evaluate the bioequivalence of two amlodipine maleate tablets, SKAD tablet (SK Pharma. Co., Ltd., Seoul, Korea, reference drug) and A-PINE tablet (Daewon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male volunteers, $22.79\;{\pm}\;1.86$ years in age and $70.08\;{\pm}\;8.68$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ crossover study was employed. After a tablet containing 6.42 mg of amlodipine maleate was orally administrated, blood was taken at predetermined time intervals over a period of 144 hr and concentrations of amlodipine in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$ (the area under the plasma concentration-time curve from time zero to 144 hr), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$, and untransformed $T_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for A-PINE/SKAD were $log\;0.9429{\sim}log \;1.1476$ and $log\;0.9l46{\sim}log\;1.1488$, respectively. Since these values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$, recommended by KFDA, it was concluded that A-PINE tablet was bioequivalent to SKAD tablet, in terms of both rate and extent of absorption.

스카드 정(말레인산암로디핀 6.42 mg)에 대한 에이핀 정의 생물학적 동등성