PII-010

S. Yi,1 M. Kim,2 S. Han,3 M. Park1; 1Department of Clinical Pharmacology & Therapeutics, Dong-A University College of Medicine and Hospital, Busan, Korea, Republic of, 2Department of Cardiology, College of Medicine, Dong-A University, Busan, Korea, Republic of, 3Department of Family Medicine, College of Medicine, Dong-A University, Busan, Korea, Republic of

BACKGROUND: Rosuvastatin and fenofibrate are often used concomitantly to treat hyperlipidemia. The aim of this study was to evaluate pharmacokinetic interactions between rosuvastatin (RSV) and fenofibrate (FF) in healthy volunteers after multiple dosing.
METHODS: A multiple-dose, open-label, three-way crossover study was performed in 36 healthy male subjects. In each treatment period, the subjects were administered either RSV 20 mg alone, or FF 160 mg alone, or those drugs concomitantly once daily for 7 days 30 minutes after the start of a light. Serial blood samples for pharmacokinetics were collected up to 96 hours after the last dosing. Plasma concentrations of RSV and FF were determined by LC/MS/MS and pharmacokinetic parameters were calculated by non-compartmental methods. Safety was evaluated throughout the study.
RESULTS: Twenty-nine subjects who completed the study were available for PK analysis. The geometric mean ratios (GMRs; [RSV+FF]/[RSV]) (90% CI) for Cmax,ss and AUCτ,ss of ATV were 1.56 (1.43-1.70) and 1.08 (1.02-1.15), respectively. In the case of FF, GMRs ([RSV+FF]/[FF], 90% CI) for Cmax,ss and AUCτ,ss were 1.04 (0.99 - 1.09) and 1.05 (1.01 - 1.09), respectively. All reported adverse events were mild in intensity, and there were no remarkable differences in safety profiles between each monotherapy and combination of RSV and FF.
CONCLUSION: Coadministration of rosuvastatin and fenofibrate resulted in similar systemic exposures and safety profiles compared to administration of rosuvastatin or fenofibrate alone. Because the significant drug-drug interaction between rosuvastatin and fenofibrate was not observed, it suggests that the dose adjustment for concomitant administration is not necessary to consider.