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KMID : 0369820050350010039
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 1 p.39 ~ p.44
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Bioequivalence of Kyongbocefaclor Capsule to Ceclor Capsule (Cefaclor 250㎎)
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조혜영/Cho HY
강현아/김세미/박찬호/오인준/임동구/문재동/이용복/Kang HA/Kim SM/Park CH/Oh IJ/Lim DK/Moon JD/Lee YB
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Abstract
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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±1.52 years in age and 67.03±7.90 kg in body weight, were divided into two groups and a randomized 2×2 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 AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and untransformed Tmax. The results showed that the differences between two formulations based on the reference drug, Ceclor, were -1.90%, 2.68% and -7.60% for AUCt, Cmax and Tmax, 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∼log1.06andlog0.92∼log1.18forAUCtandCmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.
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KEYWORD
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Cefaclor, Kyongbocefaclor, Ceclor, Bioequivalence, HPLC
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