• Journal of Pharmaceutical Investigation
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• 제29권3호
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• pp.241-245
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• 1999

Bioequivalence study of two cefpodoxime preparations, the test drug ($Banan^{\circledR}$: Hanil Pharmaceutical Co., Ltd.) and the reference drug ($Podox^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, $23.8{\pm}2.13$ years old and $63.34{\pm}4.84kg$ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 mg as cefpodoxime proxetil in a $2{\times}2$ crossover study. Plasma concentrations of cefpodoxime were analysed by HPLC method for 12 hr after administration. 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., 4.31, 1.99 and 4.30% 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., 13.89, 13.88, and 16.97% for AUC, $C_{max}$, and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within ${\times}20%$ (e.g., $-5,58{\sim}14.20$, $-7.89{\sim}11.88$, and $-7.78{\sim}16.38%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cefpodoxime were bioequivalent.