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서지반출
Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers
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  • Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers
  • Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers
저자명
Kwon. Oh-Seung,Kim. Hye-Jung,Pyo. Hee-Soo,Chung. Youn-Bok
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
2006년|14권 1호|pp.50-55 (6 pages)
발행정보
한국응용약물학회
파일정보
정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,;C_{max};and;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t;and;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{pm}25.57{mu}g.hr/ml$ for the test formulation and $64.02{pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{pm}2.14;and;5.53{pm}2.60{mu}g/ml$, respectively. The $AUC_t,;and;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,;and;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,;and;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,;and;C_{max}$ values.