Bioequivalence Study of Generic Atenolol Tablets in Healthy Thai Volunteers

NOPPAMAS ROJANASTHIEN, M.D.*, MALEEYA MANOROT, M.D.*, BOONYIUM KUMSORN, B.Sc. *

Affiliation : * Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.

AbstractTwo preparations of 50 mg and 100 mg ateno1ol tablets were evaluated for their bioequi- valence 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 para- metric 90 per cent confidence intervals of the ratio [Prenolol®JTenormin®] of AUC0 _00 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 bio- equivalent with respect to the rate and extent of absorption.

Keywords : Bioequivalence, Atenolol

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