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Pharmacokinetic non-interaction analysis in a fixed-dose formulation in combination of atorvastatin and ezetimibe
OMAR PATIÑO RODRIGUEZ
Irma Torres Roque
Maricela Martínez Delgado
Abraham Escobedo Moratilla
JOSE TRINIDAD PEREZ URIZAR
Acceso Abierto
Atribución-NoComercial-SinDerivadas
https://doi.org/10.3389/fphar.2014.00261
Pharmacokinetic drug drug interaction
Atorvastatin
Ezetimibe
Statins
LC-MS-MS
"Recent clinical research has shown that atorvastatin (ATO) in combination with cholesterol absorption inhibitor ezetimibe (EZE) significantly reduces LDLC level in patients with hypercholesterolemia, showing a superior lipid-lowering efficacy compared to statin alone. With no information currently available on the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the influence of EZE on ATO and conversely when the two drugs were coadministered. The purpose of this study was to investigate the presence of differences in the pharmacokinetic profiles of capsules containing ATO 80 mg, EZE 10 mg or the combination of both 80/10 mg administered to healthy Mexican volunteers. This was a randomized, three-period, six-sequences crossover study. 36 eligible subjects aged between 20 to 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 (C-max) were measured for each drug alone or together and tested for bioequivalence-based hypothesis. The estimation computed (90% confidence intervals) for AUC and C-max, were 96.04% (85.88-107.42%) and 9704% (82.36-114.35%), respectively for ATO EZE combination versus ATO alone, while 84.42% (77.19-92.32%) and 95.60% (82.43-110.88%), respectively, for ATO EZE combination versus EZE alone were estimated. These results suggest that ATO and EZE have no relevant pharmacokinetic drug drug interaction."
Frontiers Media S.A.
2014
Artículo
Patiño-Rodríguez O, Torres-Roque I, Martínez-Delgado M, Escobedo-Moratilla A and Pérez-Urizar J (2014) Pharmacokinetic non-interaction analysis in a fixed-dose formulation in combination of atorvastatin and ezetimibe. Front. Pharmacol. 5:261. doi: 10.3389/fphar.2014.00261
FARMACOLOGÍA
Versión publicada
publishedVersion - Versión publicada
Aparece en las colecciones: Publicaciones Científicas Biología Molecular

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