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KMID : 0369820040340060505
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 6 p.505 ~ p.511
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Bioequivalence of Bestidine(TM) Tablet to Dong-A Gaster(TM) Tablet (Famotidine 20㎎)
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박창훈/Park CH
정선경/최미희/김호현/이예리/이희주/이경률/Joung SK/Choi MH/Kim HH/Lee YR/Lee HJ/Lee KR
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Abstract
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A bioequivalence study of Bestidine™ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A Gaster™ (Dong-A Pharmaceutical Co.. Ltd.. Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a 2x2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. AUCr (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. Cma, (maximum plasma drug concentration) and Tma, (time to reach Cma,) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCr and Cma,. 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 AUCr ratio and the Cmax ratio for Bestidine™/ Gaster™ were log 0.90-log 1.06 and log 0.98-log 1.20. respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of Bestidine™ and Gaster™ with respect to the rate and extent of absorption.
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KEYWORD
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Famotidine, Gaster(TM), Bestidine(TM), Bioequivalence, HPLC
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