원문정보
초록
영어
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.
목차
실험방법
피험자 선정
피험자 관리, 약물의 투약 및 혈액 채취
시약 및 기기
검량선 작성 및 혈중 에르도스테인의 정량
생물학적 동등성 평가
실험결과 및 고찰
피험자의 선정
분석법의 개발 및 검증
생체이용률 파라미터의 산출
시험결과의 통계처리
참고문헌