슈프락스 캅셀 (세픽심 100 mg)에 대한 세피린 캅셀의 생물학적 동등성 = Bioequivalence of Cepirin Capsule to Suprax Capsule (Cefixime 100 mg)

다국어 초록 (Multilingual Abstract)

Bioequivalence of two cefixime capsules, test drug (Cepirin^R capsule: Cheiljedang Corp.) and reference drug (Suprax^R capsule: Dong A Pharm. Com.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 400mg as cefixime in a 2×2 crossover study. There was a 1-week washout period between the administrations. Blood samples were taken at predetermined time intervals for 12 hour and the plasma concentration of cefixime was determined with a HPLC method. AUC_0-12hr (area under the plasma concentration-time curve form time zero to 12 hour), C_max(maximum plasma drug concentration) and T_max (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC1-12hr, C_max and T_max between the formulations. The apparent differences of these parameters between the formulations were less than 20% (i.e., 8.62, 11.10 and 0.00% for AUC_0-12hr C_max and T_max, respectively). The powers (1-β) for AUC_0-12hr C_max and T_max. Were over 0.9. Minimal detectable difference (Δ) at α=0.05, 1-β=0.8 were less than 20% (i.e., 12.84, 11.05 and 17.99% for AUC_0-12hr C_max and T_max, respectively). The 90% confidence intervals(delta) for these parameters were also within ±20% (i.e., -0.53≤δ≤17.76. 3.23≤δ 18.97 and -12.81≤δ≤12.81 for ACU_0-12hr C_max and T_max, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two formulations of cefixime were bioequivlent.