Abstract

An open-label, 3-period study was conducted in 30 healthy postmenopausal women (mean age, 58.4years) who received a single oral dose of atorvastatin 20mg on day 1 (period 1), multiple daily dosing of bazedoxifene 40mg on days 4-11 (period 2), and coadministration of atorvastatin 20mg+bazedoxifene 40mg on day 12 (period 3). Serial blood samples were collected (24hours after bazedoxifene and 72hours after atorvastatin) and assayed for bazedoxifene, atorvastatin, and its ortho-hydroxy and para-hydroxy metabolites. Pharmacokinetic parameters were calculated using noncompartmental methods. Bazedoxifene exposure was not altered with coadministration of atorvastatin 20mg (Cmax and AUCss were within bioequivalence limits). Similarly, atorvastatin and ortho-hydroxyatorvastatin exposure was equivalent with or without coadministration with bazedoxifene. Para-hydroxyatorvastatin concentrations were below the limit of quantitation under both conditions. Cmax for atorvastatin and ortho-hydroxyatorvastatin was 14% and 18% lower, respectively, and Tmax was 20% and 34% longer, respectively, with the combination compared with atorvastatin alone. There were no serious adverse events, and no subjects discontinued the study because of safety. No clinically significant pharmacokinetic interaction was observed between bazedoxifene and atorvastatin or its active metabolites, indicating they may be safely coadministered without dosage adjustment.

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