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카르바마제핀 서방형 제제간의 생물학적 동등성 비교
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  • 카르바마제핀 서방형 제제간의 생물학적 동등성 비교
  • The Bioequivalence of Two Carbamazepine Controlled Release Formulations
저자명
김민정,이현정,류윤미,신완균,박성호,Kim. Min J.,Lee. Hyun J.,Rheu. Yoon M.,Shin. Wan G.,Park. Sung H.
간행물명
한국임상약학회지
권/호정보
1996년|6권 2호|pp.19-23 (5 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Carbamazepine is an anticonvulsant drug that has been shown to be as effective as phenytoin or phenobarbital in treatment of grand mal and complex partial seizures and is also approved as the drug of choice for treatment of the pain associated with trigerminal neuralgia. And the therapeutic or toxic effects of carbamazepine are better related to plasma concentration than to dosage, which can be attributed to interindividual variability in the pharmacokinetics. A slow rate of carbamazepine dissolution in the gastrointestinal tract is believed to be the cause of its relatively slow and erratic rate of absorption. For these reasons pharmacokinetic evaluation of newly formulated carbamazepine is neccessary. In this study, the bioequivalence in carbamazepine between the $TegretoI^{TM}$ CR tablet (Geigy Co.) and $Carmazepine^{TM}$ CR tablet (Myung In Co.) was evaluated. 12 normal volunteers (age $21~27$ years old) was divided into two groups, and a randomized cross-over study was employed. The pharmacokinetic parameters ($C_{max},;T_{max}$ and AUC) obtained of oral administration of each formulatim of carbamazepine 400 mg were evaluated and ANOVA was utilized for the statistical analysis of parameters. $C_{max};is;8.26{pm}3.1{mu}g/ml;(C.V.;37.3\%);in;TegretoI^{TM};and;9.39{pm}2.9{mu}g/ml;(C.V.;30.5\%)$ in $Carmazepine^{TM},;T_{max};is;28.0{pm}5.9;hrs(C.V.;21.1\%)$ in $Tegretol^{TM};and;24.0{pm}7.2;hrs(C.V.;30.2\%)$ in $Carmazepine^{TM}$ and AUC is $786.4{pm}360.5{mu}g{cdot}hr/ml;(C.V.;45.8\%)$ in $TegretoI^{TM};and;792.8{pm}228.6{mu}g{cdot}hr/ml;(C.V.;28.8\%)$ in $Carmazepine^{TM}$, respectively. As the result of the data, two formulations are bioequvalent, and the lower C.V. of $Carmazepine^{TM}$ in every individual can be merit.