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원보

세파클러 375 mg 서방정의 생물학적 동등성

원문정보

Bioequivalence of Cefaclor 375 mg SR Tablet

이신화, 윤민혁, 최경업, 권광일

피인용수 : 0(자료제공 : 네이버학술정보)

초록

영어

This study was carried out to compare the bioavailability of SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor 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 were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the , log-transformed , log-transformed , and . The ratios of geometric means of between test drug End reference drug were , respectively. The of test drug and reference drug was confidence intervals of mean difference of logarithmic transformed 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.

저자정보

  • 이신화
  • 윤민혁
  • 최경업
  • 권광일

참고문헌

자료제공 : 네이버학술정보

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