PMID: 16502768Mar 1, 2006Paper

Bioequivalence of an ezetimibe/simvastatin combination tablet and coadministration of ezetimibe and simvastatin as separate tablets in healthy subjects

International Journal of Clinical Pharmacology and Therapeutics
E M MigoyaJ F Paolini

Abstract

To assess the bioequivalence of an ezetimibe/simvastatin (EZE/SIMVA) combination tablet compared to the coadministration of ezetimibe and simvastatin as separate tablets (EZE + SIMVA). In this open-label, randomized, 2-part, 2-period crossover study, 96 healthy subjects were randomly assigned to participate in each part of the study (Part I or II), with each part consisting of 2 single-dose treatment periods separated by a 14-day washout. Part I consisted of Treatments A (EZE 10 mg + SIMVA 10 mg) and B (EZE/SIMVA 10/10 mg/mg) and Part II consisted of Treatments C (EZE 10 mg + SIMVA 80 mg) and D (EZE/SIMVA 10/80 mg/mg). Blood samples were collected up to 96 hours post-dose for determination of ezetimibe, total ezetimibe (ezetimibe + ezetimibe glucuronide), simvastatin and simvastatin acid (the most prevalent active metabolite of simvastatin) concentrations. Ezetimibe and simvastatin acid AUC(0-last) were predefined as primary endpoints and ezetimibe and simvastatin acid Cmax were secondary endpoints. Bioequivalence was achieved if 90% confidence intervals (CI) for the geometric mean ratios (GMR) (single tablet/coadministration) of AUC(0-last) and Cmax fell within prespecified bounds of (0.80, 1.25). The GMRs of the AUC(0-last) a...Continue Reading

Citations

May 7, 2008·Current Medical Research and Opinion·Steven HildemannChristoph Bode
Apr 30, 2015·Expert Opinion on Pharmacotherapy·Steven E Gryn, Robert A Hegele
Apr 10, 2013·European Journal of Medicinal Chemistry·Manavendra K SinghAlka Agarwal
Apr 2, 2011·Expert Review of Cardiovascular Therapy·Nkechinyere Ijioma, Jennifer G Robinson
Feb 5, 2019·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Sheng-Na HanLi-Rong Zhang
Sep 19, 2017·Expert Opinion on Drug Metabolism & Toxicology·Marilisa BoveArrigo F G Cicero
Sep 23, 2021·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·François SchieleCharalambos Vlachopoulos

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