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Title: Postmarketing pharmacokinetic and pharmacodynamic equivalence of generic and brand atenolol in Egypt
Authors: Badawi, M.A.
Wagdy, E.
Nasr, M.
Etman, M.A.
El Khordagui, L.K.
Khalil, S.A.H.
Issue Date: 2013
Language: English
Abstract: Concerns have raised regarding the postmarketing quality of generic drugs. This study assessed the pharmacokinetic and pharmacodynamic equivalence of generic and brand atenolol tablets in 24 healthy male volunteers in a single-dose, open, randomized, two-period crossover study under fasting conditions. Blood samples were collected for 24 h post dosing and assayed for atenolol using HPLC. Blood pressure and heart rate were measured at baseline and throughout blood sampling. The mean plasma concentration-time curves for both products were similar. Pharmacokinetic and statistical analysis indicated bioequivalence based on the mean ratios of log-transformed Cmax and AUC values. Both products had similar time courses of pharmacodynamic activity with a significant fall in blood pressure and heart rate [maximum after ~5 h] followed by a gradual increase towards baseline. Both products were well tolerated. Both atenolol products were bioequivalent in the postmarketing setting and can be used interchangeably in clinical practice
Description: 1-10
URI: http://www.who.int/iris/handle/10665/118606
ISSN: 1020-3397
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Appears in Collections:EMRO Journal Articles (EMHJ)



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