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파스틱 정<sup>®</sup>(나테글리니드 90 mg)에 대한 글루나테 정<sup>®</sup>의 생물학적 동등성
탁성권,이진성,최상준,서지형,이명재,강종민,류주희,홍승재,임성빈,이경태,Tak, Sung-Kwon,Lee, Jin-Sung,Choi, Sang-Joon,Seo, Ji-Hyung,Lee, Myung-Jae,Kang, Jong-Min,Ryu, Ju-Hee,Hong, Seung-Jae,Yim, Sung-Vin,Lee, Kyung-Tae 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.2
The purpose of this study was to evaluate the bioequivalence of two nateglinide tablets, $PASTIC^{(R)}$ tablet (ILDONG Pharm. Co., Ltd., Seoul, Korea, reference drug) and $GLUNATE^{(R)}$ tablet (ILHWA. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty-five healthy male volunteers, $23.1{\pm}2.3$ years in age and $69.2{\pm}8.8\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a tablet containing 90 mg of nateglinide was orally administrated, blood was taken at predetermined time intervals over a period of 8 hr and concentrations of nateglinide in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as AUCt (the area under the plasma concentration-time curve from time 0 to 8 hr), $C_{max}$ (maximum plasma drug concentration) and $TC_{max}$ (time to reach $CC_{max}$) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $GLUNATE^{(R)}/PASTIC^{(R)}$ were ${\log}1.0782{\sim}{\log}1.1626$ and ${\log}0.9621{\sim}{\log}1.1679$, respectively. Since these values were within the acceptable bioequivalence intervals of ${\log}0.80{\sim}{\log}1.25$, recommended by KFDA, it was concluded that $GLUNATER^{(R)}$ tablet was bioequivalent to $PASTIC^{(R)}$ tablet, in terms of both rate and extent of absorption.
단보 : 인체 혈장중 라베프라졸의 정량을 위한 LC-MS/MS 분석법 검증 및 단일 용량 투여에 의한 약물동태 연구
탁성권 ( Sung Kwon Tak ),서지형 ( Ji Hyung Seo ),류주희 ( Ju Hee Ryu ),최상준 ( Sang Joon Choi ),이명재 ( Myung Jae Lee ),강종민 ( Jong Min Kang ),이진성 ( Jin Sung Lee ),홍승재 ( Seung Jae Hong ),임성빈 ( Sung Vin Yim ),이경태 ( 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.1
원보 : 파스틱 정(R)(나테글리니드 90mg)에 대한 글루나테 정(R)의 생물학적 동등성
탁성권 ( Sung Kwon Tak ),이진성 ( Jin Sung Lee ),최상준 ( Sang Joon Choi ),서지형 ( Ji Hyung Seo ),이명재 ( Myung Jae Lee ),강종민 ( Jong Min Kang ),류주희 ( Ju Hee Ryu ),홍승재 ( Seung Jae Hong ),임성빈 ( Sung Vin Yim ),이경태 ( 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.2
액토스<sup>TM</sup>정(염산 피오글리타존 15 mg)에 대한 피로스<sup>TM</sup>정의 생물학적 동등성
강종민,이명재,서지형,최상준,이진성,류주희,탁성권,임성빈,홍승재,이경태,Kang, Jong-Min,Lee, Myung-Jae,Seo, Ji-Hyung,Choi, Sang-Jun,Lee, Jin-Sung,Ryu, Ju-Hee,Tak, Sung-Kwon,Yim, Sung-Vin,Hong, Seung-Jae,Lee, Kyung-Tae 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.2
The purpose of the present study was to evaluate the bioequivalence of two pioglitazone HCl tablets, $Actos^{TM}$, tablets (Lilly Korea. Ltd., Korea) as a reference drug and $Piros^{TM}$, tablets (Reyon Pharm. Co., Ltd., Korea) as test drug, according to the guideline of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing pioglitazone HCl 15 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of pioglitazone were monitored for over a period of 36 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 36 hr ($AUC_{0-36hr}$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}$ ($T_{max}$) were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{0-36hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-36hr}$ ratio and the $C_{max}$ ratio for $Piros^{TM}$/$Actos^{TM}$. were log 0.8753-log 1.1286 and log 0.8669-log 1.1734, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that the $Piros^{TM}$. tablet was bioequivalent to the $Actos^{TM}$. tablet, based on the rate and extent of absorption.
단보 : 건일로딘 캡슐(에토돌락 200 mg)에 대한 에토딘 캡슐의 생물학적동등성
이명재 ( Myung Jae Lee ),강종민 ( Jong Min Kang ),최상준 ( Sang Jun Choi ),이진성 ( Jin Sung Lee ),탁성권 ( Sung Kwon Tak ),서지형 ( Ji Hyung Seo ),류재환 ( Jae Hwan Rew ),임성빈 ( Sung Vin Yim ),이경태 ( Kyung Tae Lee ) 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.6
원보 : 액토스(TM)정(염산 피오글리타존 15 mg)에 대한 피로스(TM)정의 생물학적 동등성
강종민 ( Jong Min Kang ),이명재 ( Myung Jae Lee ),서지형 ( Je Hyung Seo ),최상준 ( Sang Jun Choi ),이진성 ( Jin Sung Lee ),류주희 ( Ju Hee Ryu ),탁성권 ( Sung Kwon Tak ),임성빈 ( Sung Vin Yim ),홍승재 ( Seung Jae Hong ),이경태 ( K 한국약제학회 2009 Journal of Pharmaceutical Investigation Vol.39 No.2