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KMID : 0369820090390060451
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 6 p.451 ~ p.456
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Bioequivalence of Rofcin Tablet to Ciprobay Tablet (Ciprofloxacin 250 mg)
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Kim Bok-Hee
Shin Young-Hee
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two ciprofloxacin tablets, Ciprobay (Bayer Korea Ltd.) and Rofcin (Binex Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The release of ciprofloxacin from the two ciprofloxacin tablets in vitro was tested using KP XIII Apparatus I method with dissolution media (0.01 M HCl). The dissolution profiles of two ciprofloxacin tablets were very similar at dissolution media. Twenty four healthy male volunteers were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet (250 mg ciprofloxacin) was orally administrated, blood was taken and the concentrations of ciprofloxacin in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated. The results showed that the differences in AUCt, Cmax and Tmax between two ciprofloxacin tablets based on the Ciprobay were -0.63%, 3.98% and -9.23%, respectively. There were no sequence effects between two tablets in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25)(e.g., log(0.9520)~log(1.0523) and log(0.9689)~log(1.1663) for AUCt and Cmax, respectively). Thus, Rofcin tablet was bioequivalent to Ciprobay tablet.
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KEYWORD
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Ciprofloxacin, Rofcin, Ciprobay, Bioequivalence, HPLC
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