Bioequivalence study of generic atenolol tablets in healthy Thai volunteers

Two preparations of 50 mg and 100 mg atenolol 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 ad...

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Main Authors: Rojanasthien N., Manorot M., Kumsorn B.
Format: Clinical Trial
Language:English
Published: 2014
Online Access:http://www.ncbi.nlm.nih.gov/pubmed/3502482
http://cmuir.cmu.ac.th/handle/6653943832/3356
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Institution: Chiang Mai University
Language: English
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spelling th-cmuir.6653943832-33562014-08-30T02:26:02Z Bioequivalence study of generic atenolol tablets in healthy Thai volunteers Rojanasthien N. Manorot M. Kumsorn B. Two preparations of 50 mg and 100 mg atenolol 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 parameters 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-infinity 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. 2014-08-30T02:26:02Z 2014-08-30T02:26:02Z 1999 Clinical Trial 0125-2208 10561948 http://www.ncbi.nlm.nih.gov/pubmed/3502482 http://cmuir.cmu.ac.th/handle/6653943832/3356 eng
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
language English
description Two preparations of 50 mg and 100 mg atenolol 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 parameters 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-infinity 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.
format Clinical Trial
author Rojanasthien N.
Manorot M.
Kumsorn B.
spellingShingle Rojanasthien N.
Manorot M.
Kumsorn B.
Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
author_facet Rojanasthien N.
Manorot M.
Kumsorn B.
author_sort Rojanasthien N.
title Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
title_short Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
title_full Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
title_fullStr Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
title_full_unstemmed Bioequivalence study of generic atenolol tablets in healthy Thai volunteers
title_sort bioequivalence study of generic atenolol tablets in healthy thai volunteers
publishDate 2014
url http://www.ncbi.nlm.nih.gov/pubmed/3502482
http://cmuir.cmu.ac.th/handle/6653943832/3356
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