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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.
LC-MS/MS를 이용한 제일크라비트정(레보플록사신 100 mg)에 대한 레사신정 100 mg의 생물학적 동등성
이경태,이진성,최상준,류주희,서지형,이명재,강종민,탁성권,강진양 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.4
The purpose of the present study was to evaluate the bioequivalence of two levofloxacin tablets, Jeil Cravit TM tablet (Jeil Pharm. Co., Ltd., Korea, reference drug) and LesacinTM tablet (Ilhwa. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets containing levofloxacin 200 mg in a 2×2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of levofloxacin were monitored for over a period of 24 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 24 hr (AUCt), maximum plasma drug concentration (Cmax) and time to reach Cmax (Tmax) 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 AUCt and Cmax. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for LesacinTM/Jeil CravitTM were log 0.9527 ~ log 0.9981 and log 0.8712 ~ log 1.0556, 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 LesacinTM tablet was bioequivalent to Jeil CravitTM tablet, in terms of rate and extent of absorption.
토파맥스 정(토피라메이트 100 mg)에 대한 토파민 정의 생물학적동등성
서지형,이명재,최상준,강종민,이진성,탁성권,이경태 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.4
The purpose of the present study was to evaluate the bioequivalence of two topiramate tablets, Topamax tablet (Janssen Korea. Co., Ltd., Seoul, Korea, reference drug) and Topamin tablet (Myungmoon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet at the dose of 100 mg topiramate in a 2×2 crossover study. There were two-weeks washout period between the doses. Plasma concentrations of topiramate were monitored by an LC-MS/MS for over a period of 96 hr after administration. AUCt (the area under the plasma concentration-time curve from time zero to 96 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed AUCt and Cmax. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for Topamin /Topamax were log0.88 ~ log1.02 and log0.87 ~ log1.03, respectively. These values were within the acceptable bioequivalence intervals of log0.80 ~ log1.25. Taken together, our study demonstrated the bioequivalence of Topamax and Topamin with respect to 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