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세파클러 375 mg서방정의 생물학적 동등성
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  • 세파클러 375 mg서방정의 생물학적 동등성
  • Bioequivalence of Cefaclor 375 mg SR Tablet
저자명
이신화,윤민혁,최경업,권광일,Lee. Shin Hwa,Yun. Min Hyuk,Choi. Kyung Eob,Kwon. Kwang Il
간행물명
한국임상약학회지
권/호정보
2003년|13권 1호|pp.13-17 (5 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},;C_{max},;T_{max},;AUC_{inf},;K_e,;t_{1/2},;V_d/F,;and;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},;t_{1/2},;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h};and;C_{max}$ between test drug End reference drug were $95.67\%;(8.55;vs;8.18{mu}g{cdot}hr/ml);and;103.86\%;(2.85;vs;2.96{mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56pm0.15;and;2.23pm0.13;hrs,;respectively.;The;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h};and;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.