Comparative 
Bioavailability Study of Sparfloxacin Formulation

Keimyung Medical Journal 2003;22(Suppl):42-49.

Comparative Bioavailability Study of Sparfloxacin Formulation

Sparfloxacin제제의 생체 이용률 비교시험

권지윤; 김수경

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; 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.

Key Words: Bioavailability, Bioequivalence, HPLC, Sparfloxacin