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KMID : 0369820040340060499
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 6 p.499 ~ p.504
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Bioequivalence of Paroxetine Tablet to Seroxat Tablet (Paroxetine 20mg)
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고인자/Ko IJ
지상철/Chi SC
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Abstract
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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 Samchullv Paroxetine tablet`` made by Samchullv Pharm. Co. and the reference product was Seroxat tablet made by GlaxoSmithKline. Twenty healthy male subjects. 22.4±2.6 years old and 63.8±4.2 kg. were divided into two groups and a randomized 2x2 cross-over study was employed. After one tablet containing 20 mg paroletine was orally administered. blood was taken at predetermined time intervals and the concentration of paroletine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters. AUCr and Cma.. 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° 0 confidence intervals of AUCr and Cmax 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 Samchullv Paroxetine tablet is bioequivalent to Seroxat tablet.
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KEYWORD
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Paroxetine, Bioequivalence, HPLC
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