Abstract
A bioequivalence study of two oral formulations of 100 mg atenolol was carried out in 24 healthy volunteers following a single dose, two-sequence, cross-over randomized design at the International Pharmaceutical Research Centre (IPRC), as a joint venture with Al-Mowasah Hospital, Amman, Jordan. The two formulations were Tensotin (Julphar, UAE) as test and Tenormin (Zeneca, UK) as reference product. Both test and reference tablets were administered with 240 ml of water to each subject after an overnight fast on 2 treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 36 h. Whole blood was analysed for atenolol by a sensitive, reproducible and accurate HPLC method with fluorescence detection capable of detecting atenolol in the range of 20-1600 ng/ml with a limit of quantitation of 20 ng/ml. Various pharmacokinetic parameters including AUC0-t, AUC0-proportional to), Cmax, Tmax, T1/2 and lambdaZ were determined from blood concentrations of both formulations and found to be in good agreement with reported values. AUC0-t, AUC0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data using ANOVA and 90% confidence interval and were found within the acceptable range of 80%-125%. Based on these statistical inferences, it was concluded that Tensotin is bioequivalent to Tenormin.
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