Evaluation for bioavailability and bioequivalence of atenolol in human
Tie Chen
Abstract
Tie Chen
Abstract
OBJECTIVE To study the difference in pharmacokinetices and relative bioavailability of atenolol produced by different factories. METHOD A single oral dose of 50 mg atenolol tablet was given respectively to 20 healthy volunteers in an open randomized crossover test. Atenolol concentration was determined by HPLC. Pharmacokinetic parameters were calculated by 3P97 program. Bioequivalence analysis was done to C max , T max and AUC 0~T .RESULTS The main pharmacokinetics of the two products (test and reference) were as follow. T max were (2.5 ± 0.8)h and (2.8 ± 0.9)h, P 0.05; C max were (326.1± 101.4)μg/L and (301.1 ± 73.3)μg/L,( P 0.05 ); AUC 0~T were (2 573.2 ± 737.6)μg·h/L and (2 485.4 ± 606.9)μg·h/L , P 0.05。 The relative bioavailability of tested tablets was (105.5 ± 27.4)%.CONCLUSION The absorption and elimination processes of two products in human body were similar and the two products were bioequivalent.
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OBJECTIVE To study the difference in pharmacokinetices and relative bioavailability of atenolol produced by different factories. METHOD A single oral dose of 50 mg atenolol tablet was given respectively to 20 healthy volunteers in an open randomized crossover test. Atenolol concentration was determined by HPLC. Pharmacokinetic parameters were calculated by 3P97 program. Bioequivalence analysis was done to C max , T max and AUC 0~T .RESULTS The main pharmacokinetics of the two products (test and reference) were as follow. T max were (2.5 ± 0.8)h and (2.8 ± 0.9)h, P 0.05; C max were (326.1± 101.4)μg/L and (301.1 ± 73.3)μg/L,( P 0.05 ); AUC 0~T were (2 573.2 ± 737.6)μg·h/L and (2 485.4 ± 606.9)μg·h/L , P 0.05。 The relative bioavailability of tested tablets was (105.5 ± 27.4)%.CONCLUSION The absorption and elimination processes of two products in human body were similar and the two products were bioequivalent.
Key concepts: Bioequivalence, Bioavailability, Atenolol, Pharmacokinetics, Crossover study, Chemistry, High-performance liquid chromatography, Chromatography