TY - JOUR
T1 - Comparative pharmacokinetics and bioequivalence of two 50 mg atenolol tablet formulations in healthy Korean male volunteers
AU - Chang, M. J.
AU - Shin, W. G.
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2012/9
Y1 - 2012/9
N2 - Atenolol is a selective βreceptor 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)and Cof 50 mg atenolol were the primary criteria for evaluation of bioequivalence. The mean standard deviation (SD) values of the C T AUC AUC k and tof 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 AUCand Cwere 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.
AB - Atenolol is a selective βreceptor 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)and Cof 50 mg atenolol were the primary criteria for evaluation of bioequivalence. The mean standard deviation (SD) values of the C T AUC AUC k and tof 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 AUCand Cwere 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.
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U2 - 10.1055/s-0032-1314853
DO - 10.1055/s-0032-1314853
M3 - Article
C2 - 22791245
AN - SCOPUS:84866303616
VL - 62
SP - 410
EP - 413
JO - Drug Research
JF - Drug Research
SN - 2194-9379
IS - 9
ER -