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Original ArticleOpen Access
Bioequivalence Study of Generic Atenolol Tablets in Healthy Thai Volunteers
Rojanasthien N 
,
Manorot M ,
Kumsorn B
,
Manorot M ,
Kumsorn B Two preparations of 50 mg and 100 mg ateno1ol tablets were evaluated for their bioequivalence
in twelve healthy Thai subjects (Prenolol®, Berlin Pharmaceutical Industry, as the test
formulations vs Tenormin®, Zeneca Limited, as the reference formulations). A single oral dose
of each preparation was administered in a randomized two-way crossover design, starting from
either 50 mg of Prenolol® vs Tenormin®, thereafter, either 100 mg of Prenolol® vs Tenormin®. The
washout period between each treatment was one week. Atenolol plasma concentrations were
determined by the HPLC technique with fluorometric detection. Pharmacokinetic parametres were
analyzed by the noncompartmental pharmacokinetic method using TOPFIT. The means and parametric
90 per cent confidence intervals of the ratio [Prenolol®/Tenormin®] of AUC0-∞ and
Cmax were 1.16 ( 1.05-1.27) and 1.23 ( 1.07-1.38) for 50 mg preparations and 1.10 ( 1.00-1.20) and 1.13
(0.95-1.31) for 100 mg preparations, respectively. These values were well within the acceptable
bioequivalence ranges. The mean differences of Tmax [Prenolol®-Tenormin®] were less than 20
per cent for both 50 mg and 100 mg preparations. Hence, Prenolol® and Tenormin® were bioequivalent
with respect to the rate and extent of absorption.
Key word : Bioequivalence, Atenolol
in twelve healthy Thai subjects (Prenolol®, Berlin Pharmaceutical Industry, as the test
formulations vs Tenormin®, Zeneca Limited, as the reference formulations). A single oral dose
of each preparation was administered in a randomized two-way crossover design, starting from
either 50 mg of Prenolol® vs Tenormin®, thereafter, either 100 mg of Prenolol® vs Tenormin®. The
washout period between each treatment was one week. Atenolol plasma concentrations were
determined by the HPLC technique with fluorometric detection. Pharmacokinetic parametres were
analyzed by the noncompartmental pharmacokinetic method using TOPFIT. The means and parametric
90 per cent confidence intervals of the ratio [Prenolol®/Tenormin®] of AUC0-∞ and
Cmax were 1.16 ( 1.05-1.27) and 1.23 ( 1.07-1.38) for 50 mg preparations and 1.10 ( 1.00-1.20) and 1.13
(0.95-1.31) for 100 mg preparations, respectively. These values were well within the acceptable
bioequivalence ranges. The mean differences of Tmax [Prenolol®-Tenormin®] were less than 20
per cent for both 50 mg and 100 mg preparations. Hence, Prenolol® and Tenormin® were bioequivalent
with respect to the rate and extent of absorption.
Key word : Bioequivalence, Atenolol
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