TY - JOUR
T1 - Absence of a significant pharmacokinetic interaction between atorvastatin and fenofibrate
T2 - A randomized, crossover, study of a fixed-dose formulation in healthy Mexican subjects
AU - Patiño-Rodríguez, Omar
AU - Martínez-Medina, Rosa María
AU - Torres-Roque, Irma
AU - Martínez-Delgado, Maricela
AU - Mares-García, América Susana
AU - Escobedo-Moratilla, Abraham
AU - Covarrubias-Pinedo, Amador
AU - Arzola-Paniagua, Angélica
AU - Herrera-Torres, José Luis
AU - Pérez-Urizar, José
N1 - Publisher Copyright:
© 2015 Patiño-Rodríguez, Martínez-Medina, Torres-Roque, Martínez-Delgado, Mares-García, Escobedo-Moratilla, Covarrubias-Pinedo, Arzola-Paniagua, Herrera-Torres and Pérez-Urizar.
PY - 2015
Y1 - 2015
N2 - Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin (ATO) and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20-50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were measured for ATO as the reference and ATO and FNO as the test product for bioequivalence design. The estimation computed (90% confidence intervals) for ATO and FNO combination versus ATO for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95, and 120,97%, respectively. These results suggest that ATO and FNO have no relevant clinical-pharmacokinetic drug interaction.
AB - Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin (ATO) and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing ATO 20 mg, or the combination of ATO 20 mg with fenofibrate (FNO) 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20-50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were measured for ATO as the reference and ATO and FNO as the test product for bioequivalence design. The estimation computed (90% confidence intervals) for ATO and FNO combination versus ATO for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95, and 120,97%, respectively. These results suggest that ATO and FNO have no relevant clinical-pharmacokinetic drug interaction.
KW - Atorvastatin
KW - Combination
KW - Fenofibrate
KW - LC-MS-MS
KW - Pharmacokinetic interaction
UR - http://www.scopus.com/inward/record.url?scp=84926455949&partnerID=8YFLogxK
U2 - 10.3389/fphar.2015.00004
DO - 10.3389/fphar.2015.00004
M3 - Artículo
SN - 1663-9812
VL - 6
JO - Frontiers in Pharmacology
JF - Frontiers in Pharmacology
IS - JAN
M1 - 004
ER -