클래리시드 정(클래리스로마이신 250mg)에 대한 터비나 정의 생물학적 동등성 = Bioequivalence Evaluation of Pylocin Tablet to Klaricid Tablet(Clarithromycin, 250 mg)

다국어 초록 (Multilingual Abstract)

The bioequivalence of two clarithromycin tablets, the Klaricid^(TM) (Ciba-Geigy Korea Ltd.) and tire Pylocin^(TM) (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers (20-26 years old) were randomly divided into two groups and a randomized 2×2 cross-over study was employed After one tablet containing 250 ㎎ of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector The pharmacokinestic parameters (area under the concentration-time curve; AUC_t maximum concentration; C_(max) and time to maximum concentration; T_(max)) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets based on Klaricid^(TM) tablet were -0.22%, -0.48% and -1.63%, respectively. The powers (1-β) for AUC_t, C_(max) and T_(max) were 99.07%, 88.15% and 99.99%, respectively. Detectable differences (A) and 90% confidence intervals (α=0.10) were all less than ±20%. All the parameters above met the criteria of KGBT 1998, indicating that Pylocin^(TM) tablet is bioequivalent to Klaricid^(TM) tablet.