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에르도스테인 제제에 대한 생물학적동등성 평가Bioequivalence Study on Two Erdosteine Preparations Commercially Available in Korea

Authors
손의동손원록조영래임성혁정지훈김지수
Issue Date
2007
Publisher
한국임상약학회
Keywords
Erdosteine; Bioequivalence; HPLC
Citation
한국임상약학회지, v.17, no.2, pp 117 - 122
Pages
6
Journal Title
한국임상약학회지
Volume
17
Number
2
Start Page
117
End Page
122
URI
https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/30874
ISSN
1226-6051
Abstract
The aim of the present study was to evaluate the bioequivalence of two erdosteine preparations. We used Erdos capsule (Daewoong Pharmaceutical Co., Korea.) as a reference drug for bioequivalence of Ellotin capsule (Dongkoo Pharmaceutical Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, 23.3±2.8 years in age and 69.5±6.6 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three capsules containing 300 mg of erdosteine (total erdosteine 900 mg) was orally administered, blood was taken at predetermined time intervals and the concentrations of erdosteine in serum were determined using HPLC with UV-detector. The analytical method was validated in specificity, accuracy, precision and linearity. The pharmacokinetic parameters such as AUCt and Cmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax. Mean±SD of AUCt and Cmax value for reference drug and test drug were 5.41±1.55 (μg/mL·hr) and 2.67±0.75 (μg/mL), and 5.05±1.30 (μg/mL·hr) and 2.59±0.59 (μg/mL), respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) for AUCt and Cmax, respectively. These results indicate that Ellotin capsule is bioequivalent to Erdos capsule.
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