Pharmacokinetic Comparison Between a Fixed-Dose Combination of Atorvastatin/Fenofibrate 20/145 mg and the Corresponding Individual Components

Abstract

Co-administration of atorvastatin and fenofibrate has demonstrated clinical benefits in patients with dyslipidemia. To improve convenience and adherence, a fixed-dose combination (FDC) of the two agents has gained interest. This study aimed to compare the pharmacokinetics (PKs) and safety of an FDC of atorvastatin/fenofibrate 20/145 mg with the corresponding individual components. A randomized, open-label, single-dose, two-sequence, two-treatment, four-period full replicated crossover study was conducted. Participants were randomly assigned to one of the two sequences and received FDC or individual components. PK parameters were estimated using a non-compartmental method. The geometric mean ratio (GMR) and its 90% confidence interval (CI) of the FDC to the individual components were calculated using mixed effect model. A total of 36 participants completed the study. The GMRs (90% CIs) for maximum plasma concentration and area under the time-concentration curve from zero to the last measurable point were 1.1038 (0.9985-1.2202) and 1.0148 (0.9745–1.0567) for atorvastatin, 1.0032 (0.9261-1.0867) and 0.9882 (0.9520–1.0258) for 2-OH atorvastatin. For fenofibric acid, the corresponding values were 0.9896 (0.8810-1.1116) and 0.9871 (0.8869-1.0986), respectively. The FDC of atorvastatin/fenofibrate 20/145 mg showed comparable PK profiles to the corresponding individual components, supporting its potential as an alternative therapeutic option for dyslipidemia with convenience.