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케타스캅셀(이부딜라스트 10 mg)에 대한 딜라스트캡슐의 생물학적동등성
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  • 케타스캅셀(이부딜라스트 10 mg)에 대한 딜라스트캡슐의 생물학적동등성
저자명
장규영,강승우,유은주,유수현,이경률,이희주,Chang. Kyu-Young,Kang. Seong-Woo,Yoo. Eun-Ju,Lew. Soo-Hyun,Lee. Kyung-Ryul,Lee. Hee-Joo
간행물명
藥劑學會誌
권/호정보
2007년|37권 3호|pp.197-203 (7 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

A bioequivalence study of $Dilast^{TM}$ Capsule (Chong Kun Dang Pharma. Co., Ltd.) to $Ketas^{(R)}$ Capsule (Han Dok Pharma. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty eight healthy male Korean volunteers received each medicine at the ibudilast dose of 20 mg in a $2{ imes}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of ibudilast were monitored by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t;and;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Dilast^{TM}$ $Capsule/Ketas^{(R)}$ Capsule were $log0.93{sim}log1.06$ and $log0.93{sim}log1.11$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Dilast^{TM}$ Capsule and $Ketas^{(R)}$ Capsule with respect to the rate and extent of absorption.