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서지반출
Pharmacokinetics and Bioequivalence of Haloperidol Tablet by Liquid Chromatographic Mass Spectrometry with Electrospray Ionization
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  • Pharmacokinetics and Bioequivalence of Haloperidol Tablet by Liquid Chromatographic Mass Spectrometry with Electrospray Ionization
  • Pharmacokinetics and Bioequivalence of Haloperidol Tablet by Liquid Chromatographic Mass Spectrometry with Electrospray Ionization
저자명
Yun. Min-Hyuk,Kwon. Jun-Tack,Kwon. Kwang-il
간행물명
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
권/호정보
2005년|28권 4호|pp.488-492 (5 pages)
발행정보
대한약학회
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정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The purpose of this study is to investigate the bioequivalence of two haloperidol 5 mg tablets, Myung In haloperidol (Myung In Pharm. Co., Ltd., test drug) and $Peridol^{R}$(Whanin Pharm. Co., Ltd., reference drug), and also to estimate the pharmacokinetic parameters of haloperidol in Korean volunteers. The bioavailability and pharmacokinetics of haloperidol tablets were examined on 24 healthy volunteers who received a single oral dose of each preparation in the fasting state in a randomized balanced 2 way crossover design. After an oral dosing, blood samples were collected for a period of 60 h. Plasma concentrations of haloperidol were determined using a liquid chromatographic electrospray mass spectrometric (LC-MS) method. The pharmacokinetic parameters were calculated with noncompartmental pharmacokinetic analysis. The geometric means of $AUC_{0-60h} and C_{max}$ between test and reference formulations were $17.21pm8.26 ngcdot/mL vs 17.31pm13.24 ngcdot/mL and 0.87pm0.74 ng/mL vs 0.85pm0.62 ng/mL$. respectively. The $90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-60h} and C_{max} were log0.9677{sim}log1.1201 and log0.8208{sim}log1.1981$, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug. The geometric means of other pharmacokinetic parameters ($AUC_{inf}. t_{1/2}, V_{d}/F, and CL/F$) between test drug and reference drug were $21.75pm8.50 ng{cdot}h/mL vs 21.77pm15.63 ng{cdot}h/mL, 29.87pm8.25 h vs 29.60pm7.56 h, 11.51pm5.45 L vs 12.90pm6.12 L and 0.26pm0.09 L/h vs 0.31pm0.17 L/h$, respectively. These observations indicate that the two formulation for haloperidol was bioequivalent and, thus, may be clinically interchangeable.