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레보프라이드 정(레보설피리드 25 mg)에 대한 레보피드 정의 생물학적 동등성
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  • 레보프라이드 정(레보설피리드 25 mg)에 대한 레보피드 정의 생물학적 동등성
저자명
조혜영,강현아,문재동,이용복,Cho. Hea-Young,Kang. Hyun-Ah,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2002년|32권 2호|pp.127-133 (7 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Levosulpiride is the 1evo-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 bioequiva1ence of two levosulpiride 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, $23.82{pm}3.26$ years in age and $69.13{pm}8.58$ kg in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 25 mg of levosulpiride was orally administered, blood was taken at predetermined time intervals and the concentrations of levosulpiride 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 on 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) $(e.g.,;log(0.93){sim}log(1.07);and;log(0.90){sim}log(1.14);for;AUC_t;and;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,;-19.47{sim}16.20;for;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Levopid tablet is bioequivalent to Levopride tablet.