TY - JOUR
T1 - Comparative bioavailability of two oral formulations of omeprazole
AU - Flores-Murrieta, Francisco J.
AU - Carrasco-Portugal, Miriam Del C.
AU - Reyes-García, Gerardo
AU - Medina-Santillán, Roberto
AU - Herrera, Jorge E.
PY - 2009
Y1 - 2009
N2 - Omeprazole is a very widely used proton-pump inhibitor. Currently, there are several branches available in Mexico, however, limited information about their bioavailabilities is available. The purpose of this study was to compare the bioavailability of two of them, Losec® and Omelcid®. Twenty-eight healthy volunteers were enrolled in this study that was carried out following the recommendations of the Declaration of Helsinki. Subjects read the protocol that was approved by the institutional research and ethics committees and gave written consent for participation. After an overnight fast, volunteers received an oral dose of 20 mg omeprazole (formulation A or B) and blood samples were obtained at selected times during 8 hours. Plasma was obtained by centrifugation and stored frozen until analyzed by a validated HPLC method. Pharmacokinetic parameters were obtained by non-compartmental analysis and values (± s.e.m.) obtained were as follows: C max 354.28 ± 51.57 and 308.95 ± 44.42 ng/ml, t max 2.26 ± 0.22 and 2.63 ± 0.24 h and AUC 8h 701.01 ± 109.34 and 774.13 ± 132.84 ng.h/ml for formulations A and B respectively. Log transformed C max and AUC 8h were compared by analysis of variance and 90% confidence limits of the parameters ratios (B/A) were 72.73-106.34% and 90.32-124.96%, for C max and AUC 8h respectively. As confidence intervals did not exceed the 70-142.9% limits for C max and 80-125% for AUC 8h, it is concluded that the formulations tested are bioequivalent.
AB - Omeprazole is a very widely used proton-pump inhibitor. Currently, there are several branches available in Mexico, however, limited information about their bioavailabilities is available. The purpose of this study was to compare the bioavailability of two of them, Losec® and Omelcid®. Twenty-eight healthy volunteers were enrolled in this study that was carried out following the recommendations of the Declaration of Helsinki. Subjects read the protocol that was approved by the institutional research and ethics committees and gave written consent for participation. After an overnight fast, volunteers received an oral dose of 20 mg omeprazole (formulation A or B) and blood samples were obtained at selected times during 8 hours. Plasma was obtained by centrifugation and stored frozen until analyzed by a validated HPLC method. Pharmacokinetic parameters were obtained by non-compartmental analysis and values (± s.e.m.) obtained were as follows: C max 354.28 ± 51.57 and 308.95 ± 44.42 ng/ml, t max 2.26 ± 0.22 and 2.63 ± 0.24 h and AUC 8h 701.01 ± 109.34 and 774.13 ± 132.84 ng.h/ml for formulations A and B respectively. Log transformed C max and AUC 8h were compared by analysis of variance and 90% confidence limits of the parameters ratios (B/A) were 72.73-106.34% and 90.32-124.96%, for C max and AUC 8h respectively. As confidence intervals did not exceed the 70-142.9% limits for C max and 80-125% for AUC 8h, it is concluded that the formulations tested are bioequivalent.
UR - http://www.scopus.com/inward/record.url?scp=77951595252&partnerID=8YFLogxK
M3 - Artículo
SN - 0083-8969
VL - 52
SP - 18
EP - 20
JO - Proceedings of the Western Pharmacology Society
JF - Proceedings of the Western Pharmacology Society
ER -