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메바코 정 (로바스타틴 20 mg)에 대한 로바로드 정의 생물학적 동등성
Bioequivalence of Lovaload Tablet to Mevacor Tablet (Lovastatin 20 mg)

송우헌   (중앙대학교 약학대학UU0001197  ); 김정민   (중앙대학교 약학대학UU0001197  ); 조성완   (중앙대학교 약학대학UU0001197  ); 김재현   (종근당 종합연구소  ); 임종래   (종근당 종합연구소  ); 신희종   (종근당 종합연구소  ); 최영욱   (중앙대학교 약학대학UU0001197  );
  • 초록

    Lovastatin, one of the potent cholesterol-lowering agents, is an inactive lactone prodrug which is metabolized to its active open acid, lovastatin acid (LVA). Bioequivalence study of two lovastatin preparations, the test drug ( $Mevacor^{\circledR}$ : Chungwae Pharmaceutical Co., Ltd.) and the reference drug ( $Lovaload^{\circledR}$ : Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Fourteen healthy male volunteers, $23.9{\pm}3.9$ years old and $67.6{\pm}8.0$ kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 160 mg as lovastatin in a $2{\times}2$ crossover study. Plasma concentrations of lovastatin acid were analysed by HPLC method for 12 hr after administration. The extent of bioavailability was obtained from the plasma concentration-time profiles of total lovastatin acid after alkaline hydrolysis of the plasma samples. By alkaline hydrolysis, trace amounts of unmetabolized lovastatin were converted to lovastatin acid. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$ and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$ , and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 7.07, 5.77 and 1.18% for AUC, $C_{max}$ , and $T_{max}$ , respectively). Minimum detectable differences(%) between the formulations at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 17.2, 15.1, and 15.9% for AUC, Cmax, and Tmax, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (e.g.. $-5.20{\sim}19.3$ , $-5.00{\sim}16.5$ , and $-10.2{\sim}12.5%$ for AUC, $C_{max}$ , and $T_{max}$ , respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of lovastatin were bioequivalent.


  • 주제어

    Bioequivalence .   Lovastatin .   $Lovaload^{\circledR}$ .   $Mevacor^{\circledR}$ .   Lovastatin acid .   HPLC.  

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  • 송우헌 (6)

    1. 1997 "파모티딘-양이온 교환수지 복합체의 약물방출 특성 및 흰쥐에서의 체내동태" 藥劑學會誌 = Journal of Korean pharmaceutical sciences 27 (4): 313~321    
    2. 1998 "아세클로페낙(100mg) 제제인 세나펜 정과 에어할 정의 생물학적동등성 평가" The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 6 (4): 423~428    
    3. 1999 "경구용 항원 수송체 모델로서 폴리락티드-글리콜리드 마이크로스피어의 입자도 조절" 藥劑學會誌 = Journal of Korean pharmaceutical sciences 29 (4): 315~321    
    4. 2011 "Solid Dispersion Formulations of Megestrol Acetate with Copovidone for Enhanced Dissolution and Oral Bioavailability" Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea 34 (1): 127~135    
    5. 2014 "In situ intestinal permeability and in vivo oral bioavailability of celecoxib in supersaturating self-emulsifying drug delivery system" Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea 37 (5): 626~635    
  • 김정민 (2)

  • Choi, Young-Wook (67)

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