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Candidate SCOPUS
바난 정 ( 세프포독심 프로세틸 100mg ) 에 대한 포독수 정의 생물학적 동등성
Bioequivalence of Podox Tablet to Banan Tablet ( Cefpodoxime Proxetil 100 mg )
조성완(Seong Wan Cho),이지혜(Ji Hye Lee),송일용(Il Yong Song),이상길(Sang Kil Lee),차영주(Young Joo Cha),최영욱(Young Wook Choi)
UCI I410-ECN-0102-2008-510-001475308

Bioequivalence study of two cefpodoxime preparations, the test drug (Banan^ⓡ: Hanil Pharmaceutical Co., Ltd.) and the reference drug (Podox^ⓡ: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 23.81±2.13 years old and 63.34 ±4.84 ㎏ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 ㎎ as cefpodoxime proxetil in a 2×2 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 α = 0.05 and 1-β=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 ±20% (e.g., -5.58∼14.20, -7.89∼11.88, and -7.78∼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.

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