에르도스테인 제제에 대한 생물학적동등성 평가

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.