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KMID : 0369820050350010045
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 1 p.45 ~ p.50
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Bioequivalence of Favid Tablet to Tarivid Tablet (Ofloxacin 100㎎)
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박완수/Park WS
조성희/이헌우/임호택/홍성제/서성훈/류재환/이경태/Cho SH/Lee HW/Im HT/Hong SJ/Seo SH/Rew JH/Lee KT
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Abstract
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The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jell Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.67±3.12 year in age and 68.50±7.23 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were deter mined using HPLC. Pharmacokinetic parameters such as AUC_(t) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t), and C_(max) and untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., log 0.94-log 1.04 and log 0.90-log 1.07 for AUC_(t) and C_(max) respectively). The major parameters. AUC_(t) and C_(max) met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.
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KEYWORD
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Ofloxacin, Validation, Bioequivalence, HPLC
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