|
KMID : 0369820040340030209
|
|
Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 3 p.209 ~ p.214
|
|
|
Bioequivalence of Roxithrin(TM) Tablet to Rulid(TM) Tablet (Roxithromycin 150 mg)
|
|
정선경/Joung SK
이윤영/조태섭/김호현/이예리/이경률/이희주/Lee YY/Cho TS/Kim HH/Lee YR/Lee KR/Lee HJ
|
|
|
Abstract
|
|
|
|
A bioequivalence study of RoxithrinTM tablet (Kukje Pharma. Ind. Co., Ltd.) to RulidTM tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a 2×2 crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. AUCt (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for RoxithrinTM/RulidTM were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of RoxithrinTM and RulidTM with respect to the rate and extent of absorption.
|
|
|
KEYWORD
|
|
|
Roxithromycin, Rulid(TM), Roxithrin(TM), Bioequivalence, HPLC
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|