|
The purpose of the present study was to evaluate the bioequivalence of two cimetidine tablets, Tagamet (Yuhan Pharm. Co., Ltd.) and Nex (Bi-nex Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cimetidine release from two cimetidine tablets in vitro was tested using KP Apparatus I method with various dissolution media (Ph 1.2,4.0,6.8 buffer solutions and water). The dissolution profiles of two cimetidine tablets were very similar at all dissolution media. Twenty four healthy male volunteers were divided into two groups with a randomized 2×2 cross-over study. After four tablets (800 mg cimetidine) were orally administrated, blood was taken and the concentrations of cimetidine in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were determined. The result showed that the differences in AUCt, and Cmax between two cimetidine tablets based on the Tagamet were -6.82% and- 12.98%, respectively, There were no sequence effects between two tablets in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., log(0.90)log(0.97) and log(0.82)log(0.93) for AUCt and Cmax, respectively), indicating that Thrumetin tablet was bioequivalent to Tagamet tablet.
|