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Bioequivalence of Kyongbocefaclor Capsule to Ceclor Capsule (Cefaclor 250 mg)

시클러 캡슐(세파클러 250 mg)에 대한 경보세파클러 캡슐의 생물학적동등성

  • Cho, Hea-Young (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Kang, Hyun-Ah (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Kim, Se-Mi (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Park, Chan-Ho (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Oh, In-Joon (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Lim, Dong-Koo (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) ;
  • Moon, Jai-Dong (Medical School, Chonnam National University) ;
  • Lee, Yong-Bok (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University)
  • 조혜영 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 강현아 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 김세미 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 박찬호 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 오인준 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 임동구 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소) ;
  • 문재동 (전남대학교 의과대학) ;
  • 이용복 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소)
  • Published : 2005.02.20

Abstract

The purpose of the present study was to evaluate the bioequivalence of two cefaclor capsules, Ceclor (Lilly Korea Co., Ltd.) and Kyongbocefaclor (Kyongbo Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of cefaclor from the two cefaclor formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $22.96{\pm}1.52$ years in age and $67.03{\pm}7.90$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After one capsule containing 250 mg of cefaclor was orally administered, blood was taken at predetermined time intervals and the concentrations of cefaclor in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Ceclor, were -1.90%, 2.68% and -7.60% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log0.91{\sim}log\;1.06\;and\;log0.92{\sim}log\;1.18\;for\;AUC_t\;and\;C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.

Keywords

References

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