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Atenolol is a water soluble, β1 selective adrenoceptor antagonist used in the treatment of angina and hypertension. It is primarily eliminated renally with minimal hepatic metabolism. The purpose of the present study was to evaluate the bioequivalence of Samchundang Atenolol (Samchundoang Pharmaceutical Co., Korea.) to Tenolmin(Hyundai Pharmaceutical Inc. Co., Korea). The atenolol relesase from the two atenolol tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, 22.83±1.99 years in age and 65.82±7.15 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 50 mg of atenolol was orally administered, blood was taken at predetermined time intervals and the concentrations of atenolol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two atenolol tablets were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUCt, Cmax and Tmax between two tablets based on the Tenolmin were 3.74%, 4.38% and 17.77%, 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(0.98)~log(1.11) and log(0.95)~log(1.15) for AUCt and Cmax, respectively), indicating that Samchundang Atenolol tablet is bioequivalent to Tenolmin tablet.
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