레보프라이드 정 (레보설피리드 25 mg)에 대한 레보셀 정의 생물학적동등성 = Bioequivalence of revocel tablet to levopride tablet (levosulpiride 25 mg)

다국어 초록 (Multilingual Abstract)

The aim of the present study was to evaluate the bioequivalence of two levosulpiride tablets, Levopride (SK Pharmaceutical Co., Ltd.) and Revocel (Kwang Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, 23.7±1.8 year in age and 66.8±7.6 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three tablets containing 75 mg of levosulpiride were orally administered, blood was taken at predetermined time intervals and the concentrations of levosulpiride in plasma were determined using HPLC with fluorescence detector. The dissolution profiles of two levosulpiride tablets were not significantly different at all dissolution media. 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). The results showed that the differences between two formulations were 2.59%, -2.04% and 8.94% for AUC_(t), C_(max) and T_(max), respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.95~log1.13 and log0.91~log1.06 for AUC_(t) and C_(max)). Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Levopride tablet and Revocel tablet are bioequivalent.