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이팩사<sup>®</sup> XR서방캅셀(벤라팍신, 75 mg)에 대한 벤팍신<sup>®</sup>OR서방정의 생물학적동등성
디펜드라 쿠마 아리얼,오수연,조종태,김형건,김윤균,Aryal, Dipendra Kumar,Oh, Soo-Yeon,Cho, Jong-Tae,Kim, Hyung-Gun,Kim, Yoon-Gyoon 한국약제학회 2007 Journal of Pharmaceutical Investigation Vol.37 No.6
To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.
제스트릴<sup>®</sup>정(리시노프릴, 10 mg)에 대한 리시헥살<sup>®</sup>정의 생물학적동등성
오수연,디펜드라 쿠마 아리얼,조종태,김형건,김윤균,Oh, Soo-Yeon,Aryal Dipendra Kumar,Cho, Jong-Tae,Kim, Hyung-Gun,Kim, Yoon-Gyoon 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.4
Lisinopril is one of the angiotensin-converting enzyme inhibitors, which have been used for treatment of hypertension and heart failure. The aim of this study was to evaluate the bioequivalence of two lisinopril tablet, $Lisihexal^{\circledR}$ and $Zestril^{\circledR}$ as a test and reference, respectively. The study was came out on 28 healthy male Korean volunteers in $2{\times}2$ crossover design. An analytical method with LC-MS-MS was developed for the quantification of lisinopril and enalapril(IS) using SPE method. The condition was selective, sensitive and precise in human plasma, that was enough for the pharmacokinetic study of lisinopril. The pharmacokinetic parameters such as $AUC_t,\;AUC_{inf},\;C_{max},\;T_{max}\;and\;t_{1/2}$ were calculated and ANOVA test was used for the statistical analysis of the parameters using log transformed $AUC_t,\;AUC_{inf}\;and\;C_{max}$. $t_{1/2}$ of test and reference drugs were calculated $11.4{\pm}5.1\;and\;16.1{\pm}9.9\;hr$, respectively. The 90% confidence intervals of $AUC_t,\;AUC_{inf}\;and\;C_{max}$ were log 0.9245$\sim$log 1.0603, log 0.9270$\sim$log 1.0601 and log 0.9548$\sim$log 1.1009, within the acceptable range of log 0.8 to log 1.25 by KFDA bioequivalence criteria. Two medications of lisinopril were evaluated bioequivalent and thus may be prescribed interchangeably.