Abstract
The purpose of the present study was to evaluate the bioequivalence of two nizatidine capsules, Axid (Lilly Korea Pharm. Co., Ltd.) and Nex (Bi-nex Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The nizatidine release from the two nizatidine capsules in vitro was tested using KP Apparatus method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). The dissolution prefers of two nizatidine capsules were very similar at all dissolution media. Twenty four normal male volunteers were divided into two groups with a randomized 22 crossover study. After two capsules (300 mg nizatidine) were orally administrated, blood was taken and the concentrations of nizatidine in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were determined. The result showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two nizatidine capsules based on the Axid were -6.16%, -8.26% and -1.82%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(125)(e.g., $log(0.91){\sim}log(0.97)$ and $log(0.85) {\sim}log(0.99)$ for $AUC_t$ and $C_{max}$ respectively), indicting that Nex capsule is bioequivalent to Axid capsule.
