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Paper Information

Journal:   DARU JOURNAL OF PHARMACEUTICAL SCIENCE   2003 , Volume 11 , Number 3; Page(s) 95 To 98.
 
Paper: 

BIOEQUIVALENCE STUDY OF ATENOLOL: PHARMACOKINETIC AND PHARMACODYNAMIC EVALUATION

 
 
Author(s):  MIR FAZAELIAN A., TABATABAEIFAR M., REZAEI SAEID, MAHMOUDIAN M.*
 
* Department of Pharmacology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
 
Abstract: 

This study was designed to assess pharmacokinetic parameters and pattern of pharmacodynamic effects (heart rate and blood pressure) of 100 mg Atenolol tablets in comparison with those of 100 mg Tenormin tablets as reference. A double blind cross over study was carried out among 12 healthy male subjects. A HPLC system using RP-C18 column and fluorescence detector was used to assess Atenolol in plasma. Heart r ate and blood p pressure was measured by the t rained clinic staff. Peak levels were observed about 2.97h for Atenolol and 3.73h for Tenormin after oral dosing. Cmax values for both formulations were about 0.49 µg/ml. AUC0-24was about 4.89 µg.h/ml for the test and 5.31 µg.h/ml for the reference group. Atenolol given orally caused a significant reduction in heart rate, systolic and diastolic blood pressure after administration of two formulations (P<0.05). It is concluded that two formulations are not significantly different in terms of pharmacodynamic and pharmacokinetic parameters which were studied.

 

 
Keyword(s): ATENOLOL, PHARMACOKINETICS, PHARMACODYNAMICS, BLOOD PRESSURE, HEART RATE
 
References: 
 
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