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세로자트정(파록세틴 20 mg)에 대한 삼천리파록세틴정의 생물학적동등성
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  • 세로자트정(파록세틴 20 mg)에 대한 삼천리파록세틴정의 생물학적동등성
저자명
고인자,지상철,Ko. In-Ja,Chi. Sang-Cheol
간행물명
藥劑學會誌
권/호정보
2004년|34권 6호|pp.499-504 (6 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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Paroxetine, a potent and selective serotonine reuptake inhibitor, has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchully Paroxetine $tablet^{circledR}$ made by Samchully Pharm. Co. and the reference product was Seroxat $tablet^{circledR}$ made by GlaxoSmithKline. Twenty healthy male subjects, $22.4{pm}2.6$ years old and $63.8{pm}4.2;kg$, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 20 mg paroxetine was orally administered, blood was taken at predetermined time intervals and the concentration of paroxetine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.84-log 1.16 and log 0.85-log 1.14, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Samchully Paroxetine tablet is bioequivalent to Seroxat tablet.