Relative bioavailability and bioequivalence of Atenolol tablet in healthy male volunteers
Lixin Yin
Abstract
Lixin Yin
Abstract
OBJECTIVE To determine the relative bioavailability and bioequivalence of atenolol tablet in healthy male volunteers.METHODS In a randomized two-period cross-over study,a single oral dose of 50mg atenolol tablet(test and reference preparation) were given to 22 healthy male volunteers.The concentrations of atenolol in plasma were determined by HPLC-fluorescence method.The pharmacokinetic parameters of the two preparations and the relative bioavailability of atenolol were calculated with statistical analysis.RESULTS The relative bioavailability of atenolol in test were 100.6%±33.0%.There were no significant difference with the pharmacokinetic parameters between test and reference preparation(P0.05).The 90% confidence interval of AUC_(0~t) was 90.72%-111.86%,and C_(max) was 87.48%-117.29%.CONCLUSION The two preparations are bioequivalent.
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OBJECTIVE To determine the relative bioavailability and bioequivalence of atenolol tablet in healthy male volunteers.METHODS In a randomized two-period cross-over study,a single oral dose of 50mg atenolol tablet(test and reference preparation) were given to 22 healthy male volunteers.The concentrations of atenolol in plasma were determined by HPLC-fluorescence method.The pharmacokinetic parameters of the two preparations and the relative bioavailability of atenolol were calculated with statistical analysis.RESULTS The relative bioavailability of atenolol in test were 100.6%±33.0%.There were no significant difference with the pharmacokinetic parameters between test and reference preparation(P0.05).The 90% confidence interval of AUC_(0~t) was 90.72%-111.86%,and C_(max) was 87.48%-117.29%.CONCLUSION The two preparations are bioequivalent.
Key concepts: Bioequivalence, Atenolol, Bioavailability, Chemistry, Pharmacokinetics, Pharmacology, Confidence interval, High-performance liquid chromatography