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Bioequivalence and Pharmacokinetics of 70 mg Alendronate Sodium Tablets by Measuring Alendronate in Plasma
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  • Bioequivalence and Pharmacokinetics of 70 mg Alendronate Sodium Tablets by Measuring Alendronate in Plasma
  • Bioequivalence and Pharmacokinetics of 70 mg Alendronate Sodium Tablets by Measuring Alendronate in Plasma
저자명
Yun. Min-Hyuk,Woo. Jong-Su,Kwon. Kwang-Il
간행물명
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
권/호정보
2006년|29권 4호|pp.328-332 (5 pages)
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대한약학회
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정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The bioequivalence and pharmacokinetics of alendronate sodium tablets were examined by determining the plasma concentration of alendronate. Two groups, consisting of 24 healthy volunteers, each received a 70 mg reference alendronate sodium tablet and a test tablet in a $2{ imes}2$ crossover study. There was a 6-day washout period between doses. The plasma alendronate concentration was monitored for 7 h after the dose, using HPLC-Fluorescence Detector (FD). The area under the plasma concentration-time curve from time 0 to the last sampling time at 7 h $(AUC_{0-7h})$ was calculated using the linear-log trapezoidal rule. The maximum plasma drug concentration $(C_{max})$ and the time to reach $C_{max}(T_{max})$ were derived from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_{0-7h};and;C_{max}$, and untransformed $T_{max}$. For the test medication versus the reference medication, the $AUC_{0-7h};were;87.63{pm}29.27;vs.;102.44{pm}69.96ng;h;mL^{-1}$ and the $C_{max}$ values were $34.29{pm}13.77;vs.;38.47{pm}24.39ng;mL^{-1}$ respectively. The $90\%$ confidence intervals of the mean differences of the logarithmic transformed $AUC_{0-7h}$ and $C_{max}$ values were log 0.8234-log 1.1597 and log 0.8222-log 1.1409, respectively, satisfying the bioequivalence criteria guidelines of both the US Food and Drug Administration and the Korea Food and Drug Administration. The other pharmacokinetic parameters for the test drug versus reference drug, respectively, were: $t_{1/2},;1.87{pm}0.62;vs.;1.77{pm}0.54;h;;V/F,;2061.30{pm}986.49;vs.;2576.45{pm}1826.05;L;;CL/F,;835.32{pm}357.35;vs.;889.48{pm}485.87;L;h^{-1}; K_{el},;0.42{pm}0.14;vs.;0.40{pm}0.18;h^{-1};;Ka,;4.46{pm}3.63;vs.;3.80{pm}3.64;h^{-1};;and;T_{lag},;0.19{pm}0.09;vs.;0.18{pm}0.06;h$. These results indicated that two alendronate formulations(70-mg alendronate sodium) were biologically equivalent and can be prescribed interchangeably.