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푸로작 캅셀(플루옥세틴 20 mg)에 대한 루세린 캅셀의 생물학적 동등성
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  • 푸로작 캅셀(플루옥세틴 20 mg)에 대한 루세린 캅셀의 생물학적 동등성
저자명
김수진,심영순,임동구,오인준,서순팔,이용복,Kim. Soo-Jin,Sim. Young-Sun,Lim. Dong-Koo,Oh. In-Joon,Suh. Soon-Pal,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
1999년|29권 2호|pp.151-156 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Bioequivalence of two fluoxetine capsules, the $Prozac^{circledR}$ (Daewoong Lilly Pharmaceutical Co., Ltd.) and the $Lucetin^{circledR}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Twenty normal male volunteers $(21{sim}30;years;old)$ were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After three capsules containing 20 mg of fluoxetine per capsule were orally administered, blood was taken at predetermined time intervals, and the concentrations of fluoxetine in serum were determined using HPLC method with UV detector. The pharmacokinetic parameters ($AUC_t$, $C_{max}$ and $T_{max}$) were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two capsules based on $Lucetin^{circledR}$ capsules were -8.01 %, -7.02% and 1.49%, respectively. The powers $(1-{eta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 84.72%, 96.68% and 83.06%, respectively. Detectable differences $({Delta})$ and confidence intervals were all less than ${pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Lucetin^{circledR}$ capsule is bioequivalent to $Prozac^{circledR}$ capsule.