메바코정(로바스타틴 20mg정)에 대한 동성로바스타틴정의 생물학적 동등성

Bioequivalence of Dong Sung Lovastatin Tablet to Mevacor Tablet(Lovastatin 20mg)

A bioequivalence study of LovastatinTM tablets(Dong Sung Pharmaceutical Co., Korea) to MevacorTM tablets(Choong Wae Pharmaceutical Co., Korea) was conducted according to the guidelines(No. 98-56) of Korea Food and Drug Administration(KFDA). Each tablet contained 20mg of lovastatin dose of 80mg(I.e.,four tablets) in a 2 x 2 crossover study. There was a washout period of a week between the dose of the two formulations. Plasma concentrations of lovastatin acid were monitered by a GC/MS method for over a periods of 12hr after each administration. The area under the plasma concentration-time curve from time zero to 12hr(AUC) was calculated by a linear trapezoidal method. The maximum plasma drug concentration(Cmax) and the time to reach Cmax(Tmax) were complied from plasma drug concentration-time data. Analysis of variance(ANOVA) of these parameters revelaed that there are no differences in AUC and Cmax between the formulations. The apparent differnces between the formulations in these parameters were 4.87 and 8.03% for AUC and Cmax respectively. Minimum detectable difference(%) at a=0.1,1-b=0.8 were 17.84 and 15.36% for AUC and Cmax respectively. The 90% confidence intervals were -15.30~5.56 and -17.02~0.95% for AUC and Cmax, repectively. Thus the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating MevacorTM tablets and Dong Sung LovastatinTM tablets are bioequivalent.