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KMID : 0369820050350040303
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 4 p.303 ~ p.308
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Bioequivalence of FLUTAL Tablet to SOMALGEN Tablet (Talniflumate 370 mg)
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이헌우/Lee HW
조성희/박완수/임호택/김영관/류재환/이경태/Cho SH/Park WS/Im HT/Kim YK/Rew JH/Lee KT
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two talniflumate tablets, SOMALGEN tablet (Kun Wha Pharm. Co., Ltd., Seoul, Korea, reference drug) and FLUTAL tablet (Kukje Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the talniflumate dose of 740 mg in a 2±2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of niflumic acid were monitored by an HPLC-UV for over a period of 14 hr after the administration. AUCt(the area under the plasma concentration-time curve from time zero to 14 hr) was calculated by the linear trapezoidal rule method. Cmax(maximum plasma drug concentration) and Tmax(time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt, Cmax and untransformed Tmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUCt, ratio and the Cmax ratio for SOMALGEN/FLUTAL were log0.8510∼log1.0318 and log0.9264∼log1.0607, respectively. These values were within the acceptable bioequivalence intervals of log0.80∼log1.25. Taken together, our study demonstrated the bioequivalence of SOMALGEN and FLUTAL with respect to the rate and extent of absorption.
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KEYWORD
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Talniflumate, Niflumic acid, HPLC, Bioequivalence
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