2006Huaxi yaoxue zazhiRequires access

Relative bioavailability and bioequivalence of Atenolol tablet in healthy male volunteers

Lixin Yin

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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.

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Available 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.

Key concepts: Bioequivalence, Atenolol, Bioavailability, Chemistry, Pharmacokinetics, Pharmacology, Confidence interval, High-performance liquid chromatography

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