Arzneimittelforschung 2012; 62(09): 410-413
DOI: 10.1055/s-0032-1314853
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Comparative Pharmacokinetics and Bioequivalence of Two 50 mg Atenolol Tablet Formulations in Healthy Korean Male Volunteers

M. J. Chang
1   College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, South Korea
,
W. G. Shin
1   College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, South Korea
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Weitere Informationen

Publikationsverlauf

received 09. März 2012

accepted 17. Mai 2012

Publikationsdatum:
12. Juli 2012 (online)

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Abstract

Atenolol is a selective β1 receptor antagonist that is available as a racemic mixture. The objective of this study was to compare the pharmacokinetics and evaluate the bioequivalence of 50 mg atenolol test and reference formulations in 24 healthy Korean male volunteers.

This study was a single-dose, randomized, open-label, 2 period crossover study. 24 healthy Korean male volunteers randomly received 50 mg of either test or reference atenolol formulations in a 2×2 crossover study. There was a 1 week washout period between doses. The area under the curve (AUC)0–24h and Cmax of 50 mg atenolol were the primary criteria for evaluation of bioequivalence.

The mean ± standard deviation (SD) values of the Cmax, Tmax, AUC0–24h, AUC0–∞, ke, and t1/2 of the test and reference formulations were 268.4 (78.96) and 256.9 (79.34), 2.750 (0.9555) and 3.104 (1.053), 1 981 (729.2) and 1 872 (604.8), 2228 (697.1) and 2 187 (628.5), 0.1332 (0.02748) and 0.1421 (0.04223), 5.419 (1.110) and 5.442 (2.357), respectively. The 90% confidence intervals for AUC0–24h and Cmax were 0.9037–1.166 and 0.9169–1.1987, respectively. These results were within the accepted bioequivalence range of 0.80–1.25, which satisfied the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. In conclusion, the findings of this study indicate that the 2 formulations of 50 mg atenolol that were tested are bioequivalent. Therefore, these formulations may be prescribed interchangeably.