세프라딘 캅셀(세프라딘 250 mg)의 생물학적 동등성

Bioequivalence of Cephradine Capsules (Cephradine 250 mg)

Cephradine is an orally absorbed cephalosporin with a broad spectrum of activity against gram-positive and gram-negative bacteria and is highly resistant to beta- lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cephradine capules, Cephradine capsule (Donggu Pharmaceutical Co., reference drug) and Cephradine capsule (Shinpoong Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration. Lrenty-six normal volunteers,24.6 +/- 3.70 years in age and 62.4 7 +/- 8.99 kg in body weight, were divided into two groups and a randomized 2 x 2 cross-over study was employed. After one capsule containing 250 mg of cephrdine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephrdine in serum were deter- mined using HPLC with UV detector, The pharmacokinetic parameters such as AUC1, Cmax And Tmax were calculated and ANOYA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt,Cmax and Tme between two products were 2.89%, 1.05% and 1.06%, respective1y; when calculated against the reference drug. The 90% confidence intervals were within log0.8 ≤ δ ≤ log1.25 (e.g., log0.9803 ≤ δ ≤ log1.0734 and logo.9674 ≤ δ≤log1.220 for AUCt, and Cmax, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Cephradine capsules (Shinpoong Pharmaceutical Co.) is bioequivalent to Cephradine capsules (Donggu Pharmaceutical Co.).