레보플록사신 제제인 제일크라비트정에 대한 레보록신정의 생물학적동등성시험

Abstract

This study was conducted to evaluate the bioequivalence of two levofloxacin formulations, Jeil Cravit J.IC® tablet (Jeil Pharm. Co., Ltd. Korea, reference drug) and Levoloxin® tablet (Korea United Pharm Inc., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-six healthy Korean volunteers employed a randomized, 2 × 2 crossover study with a one-week washout period. The two products were administered in 2 tablets (200 mg of levofloxacin) as single oral dose for this study. After dosing, serial blood samples were collected for a period of 24 hours. Plasma levofloxacin concentrations were measured by using high performance liquid chromatography (HPLC) and UV detector. The pharmacokinetic parameters including area under the concentration from time zero to 24 hr (AUCt), maximum plasma drug concentration (Cmax), and time to reach Cmax (Tmax) were obtained from plasma concentration data of each time. Analysis of variance (ANOVA) test was utilized for the statistical analysis of parameters using logarithmically transformed AUCt and Cmax. Mean ratio of AUCt and Cmax of Levoloxin® tablet were 0.991 (90% confidence interval: 0.9484 ≤ δ≤ 1.0360) and 1.06 (90% confidence interval: 0.9899 ≤ δ≤ 1.1366) compared to those of Jeil Cravit J.IC® tablet respectively. Mean Tmax of Levoloxin® tablet was 1.008 ± 0.419 hr and that of Jeil Cravit J.IC® tablet was 1.187 ± 0.749 hr. These results satisfied the bioequivalence criteria of KFDA guidelines in AUCt and Cmax, In all of these results, we concluded that Levoloxin® tablet was to be bioequivalent to Cravit J.IC® tablet in terms of bioavailability.