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KMID : 0369820040340040311
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 4 p.311 ~ p.317
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Bioequivalence of Gomcillin(TM) Capsule to Famoxin(TM) Capsule (Amoxicillin 500 mg)
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이윤영/Lee YY
최미희/이경률/이희주/Choi MH/Lee KR/Lee HJ
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Abstract
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A bioequivalence study of GomcillinTM capsules (DAEWOONG Pharmaceutical Co., Korea) to FamoxinTM capsules (Dong Wha Pharm. Ind. Co., Korea) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the amoxicillin dose of 500 mg in a 2×2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of amoxicillin were monitored by a high-performance liquid chromatography for over a period of 8 hours after the administration. AUCt (the area under the plasma concentration-time curve from time zero to 8 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 and Cmax. 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 GomcillinTM/FamoxinTM were log0.91∼log1.03 and ;log0.93∼log1.10, respectively. These values were within the acceptable bioequivalence intervals of log0.80∼log1.25. Thus, our study demonstrated the bioequivalence of GomcillinTM and FamoxinTM with respect to the rate and extent of absorption.
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KEYWORD
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Amoxicillin, Gomcillin(TM), Famoxin(TM), Bioequivalence, HPLC
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