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록소프로펜 정의 생물학적 동등성 평가
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  • 록소프로펜 정의 생물학적 동등성 평가
  • Bioequivalence of Loxoprofen Tablets
저자명
김수진,오인준,신상철,이용복,조행남,서순팔,Kim. Sue-Jin,Oh. In-Joon,Shin. Sang-Chul,Lee. Yong-Bok,Joh. Haeng-Nam,Suh. Soon-Pal
간행물명
한국임상약학회지
권/호정보
1997년|7권 2호|pp.73-80 (8 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The bioequivalence of two loxoprofen tablets between the $Loxonin^{TM}$ (Dong Hwa Pharmaceutical Co., Ltd.) and the $Lokpen^{TM}$ (Dong Il Pharmaceutical Co., Ltd.) was evaluated. 12 normal male volunteers (age $21sim27$ years old) were divided into two groups and a randomized cross-over study was employed. After one tablet containing 60 mg of loxoprofen sodium anhydrous was orally administered, blood was taken at predetermined time intervals and the concentration of loxoprofen in serum was determined with an HPLC method using UV/VIS detector. The pharmacokinetic parameters ($C_{max},;T_{max}$, and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},;T_{max}$, and $AUC_t$ between two tablets were $1.13\%,;0\%,;and;0.69\%$, respectively The powers (1-${eta}$) for $C_{max},;T_{max}$, and $AUC_t$ were $84.88\%,;88.61\%,;and;84.81\%$, respectively Detectable differences ($delta$) and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Lokpen^{TM}$ tablet is bioequivalent to $Loxonin^{TM}$ tablet.