레보프라이드 정(레보설피리드 25 mg)에 대한 레보피드 정의 생물학적 동등성 = Bioequivalence of Levopid Tablet to Levopride Tablet (Levosulpiride 25 mg)

다국어 초록 (Multilingual Abstract)

Levosulpiride is the levo-enantiomer form of racemic sulpiride, a benzamide derivative selectively inhibiting dopaminergic D_2 receptors at the trigger zone both in the central nervous system and in the gastrointestinal tract. The purpose of the present study was to evaluate the bioequivalence of two levousulpiride tablets. Levopride (SK Pharmaceutical Co. Ltd.) and Levopid (Dae Won Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The levosulpiride release from the two levosulpiride tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight normal male volunteers, 23.82 ±3.26 years in age and 69.13 ±8.58 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 2.5 ㎎ of levousulpiride was orally administered, blood was taken at predetermined time intervals and the concentrations of lovosulpiride in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two levosulpiride tablets were very similar at all dissolution media. Besides, the 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 and untransformed T_max. The results showed that the differences in AUC_t, C_max and T_max between two tablets based in the Levopride were －1.17％, 1.20％ and －1.09％, respectively. There were no sequence effects between two tablets in these parameters. The 90％ confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(0.93)∼log(1.07) and log(0.90)∼log(1.14) for AUC_t and C_max, respectively). The 90％ confidence interval using untransformed data was within ±20％ (e.g., －19.47 ∼16.20 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Levopid tablet is bioequivalent to Levopride tablet.