title: Absence of a significant pharmacokinetic interaction between atorvastatin and fenofibrate: a randomized, crossover, study of a fixed-dose formulation in healthy Mexican subjects.
abstract: 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.
authors: Dixpertia, Investigación Biofarmacéutica y Farmacológica S.C. San Luis Potosí San Luis Potosí, Mexico.
authors: Omar
authors: O
authors: Patiño-Rodríguez
authors: Laboratorio de Farmacología y Fisiología, Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí San Luis Potosí, Mexico.
authors: Rosa María
authors: RM
authors: Martínez-Medina
authors: Dixpertia, Investigación Biofarmacéutica y Farmacológica S.C. San Luis Potosí San Luis Potosí, Mexico.
authors: Irma
authors: I
authors: Torres-Roque
authors: Dixpertia, Investigación Biofarmacéutica y Farmacológica S.C. San Luis Potosí San Luis Potosí, Mexico.
authors: Maricela
authors: M
authors: Martínez-Delgado
authors: Laboratorio de Investigación Traslacional en Farmacología, Facultad de Medicina, Universidad Autónoma de San Luis Potosí San Luis Potosí, Mexico.
authors: América Susana
authors: AS
authors: Mares-García
authors: Dixpertia, Investigación Biofarmacéutica y Farmacológica S.C. San Luis Potosí San Luis Potosí, Mexico.
authors: Abraham
authors: A
authors: Escobedo-Moratilla
authors: Instituto de Investigación Clínica de Occidente S.A. de C.V. Zapopan Jalisco, Mexico.
authors: Amador
authors: A
authors: Covarrubias-Pinedo
authors: Laboratorios Senosiain S.A. de C.V. Distrito Federal Mexico City, Mexico.
authors: Angélica
authors: A
authors: Arzola-Paniagua
authors: Laboratorios Senosiain S.A. de C.V. Distrito Federal Mexico City, Mexico.
authors: José Luis
authors: JL
authors: Herrera-Torres
authors: Laboratorio de Farmacología y Fisiología, Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí San Luis Potosí, Mexico.
authors: José
authors: J
authors: Pérez-Urizar
keywords: LC-MS-MS; atorvastatin; combination; fenofibrate; pharmacokinetic interaction