Sparfloxacin제제의 생체 이용률 비교시험

Abstract

This study was conducted to evaluate the bioavailability of sparfloxacin formulation in healthy Korean volunteers. Furthermore, the bioequivalence of Spacin® tablet, a sparfloxacin preparation from Korea United Pharm, Inc., was determined in comparison with Spara® tablet, a sparfloxacin preparation of Sam-a Inc. The study employed a randomized, two-way crossover Latin square design with a 10 day washout period. The test product was Spacin® tablet (Korea United Pharm Inc, Republic of Korea) and the reference drug was Spara® tablet (Sam-a Inc, Republic of Korea). The two products were administered in 200mg single oral doses into 26 healthy Korean volunteers. Serial blood samples were collected for a period of 60 hours. Plasma saparfloxacin concentrations were measured by HPLC using UV detector, and the pharmacokinetic parameters including AUCt, Cmax, Tmax, and half-life (t1/2) were determined from plasma. Both formulations were well tolerated in 26 volunteers. Mean ratio of AUCt and Cmax of spacin® tablet were 0.956 (90% confidence interval:0.8987≤δ≤1.0177) and 0.911 (90% confidence interval: 0.8909≤δ≤1.0007) compared to those of Spara® tablet. Mean t1/2 of spacin® tablet was 18.43 ± 3.56 hr and that of Spara® tablet was 18.02 ± 2.55 hr. The power (1-β) for AUCt was above 90% and that of Cmax was 89.4%. The parmacokinetic parameters (AUCt, Cmax and Tmax) were analyzed statistically (ANOVA and 90% confidence intervals) With K-BE test 2002 (KFDA). No significant differences between two formulations were observed in terms of AUCt and Cmax, the main pharmacokinetic parameters used for bioequivalence evaluation. The results satisfied the bioequivalence criteria of KFDA guidelines, and Spacin® tablet was determined to be bioequivalent to Spara® tablet.