The objective of this study was to compare the steady state (SS) PK of Pitavastatin (NK-104) before and after coadministration with either fenofibrate or gemfibrozil as interactive agents for 7 days. In this single-center, open-label, one-sequence, crossover study, 24 healthy subjects aged 18 to 45 years who met qualifying criteria were enrolled. PK of NK-104 and its lactone at SS were assessed after administration of NK-104 (4mg QD) for Days 1 through 6 and after coadministration with either fenofibrate (160mg QD) or gemfibrozil (600mg BID) on Days 8 through 14. Differences in log transformed PK parameters between the two treatments were estimated using ANOVA and their associated 90% confidence intervals (CI) were inversely transformed to obtain the ratios. No drug-drug interaction was claimed if the 90% CI fell entirely within the range of 80%-125%. Fenofibrate coadministration showed equivalence in the CmaxSS of NK-104, NK-104 lactone and AUC(0–24)SSof NK-104 lactone and increased the NK-104 AUC(0–24)SS by 18%. Gemfibrozil coadministration increased the CmaxSS of NK-104 by 31%, AUC(0–24)SS by 45% and decreased the CmaxSS of NK-104 lactone by 28% and AUC(0–24)SS by 15%. Both fenofibrate and gemfibrozil were observed to lower the amount of NK-104 lactone excreted in urine and NK-104 lactone renal clearance. The coadministration of either fenofibrate or gemfibrozil with NK-104 for 7 days was found to be safe, well tolerated and without clinically significant PK interactions. Clinical Pharmacology & Therapeutics (2004) 75, P33–P33; doi: 10.1016/j.clpt.2003.11.125
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Philip Mathew (2004) studied this question.