The Drug-drug Interactions of Pitavastatin (NK-104), a Novel HMG-CoA Reductase Inhibitor and Cyclosporine
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Accession number;03A0323481
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| Title;The Drug-drug Interactions of Pitavastatin (NK-104), a Novel HMG-CoA Reductase Inhibitor and Cyclosporine |
| Author;
()
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.4;PAGE.381-389(2003)
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| Figure&Table&Reference;FIG.5, TBL.4, REF.27 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The drug-drug interactions of NK-104 (pitavastatin), a novel HMG-CoA reductase inhibitor and cyclosporin A (CsA) were investigated in 6 healthy volunteers. Under abstinence from breakfast, 2 mg of pitavastatin was given to all the subjects in every morning for 6 days. On day 4, the blood samples were collected to measure the plasma concentrations of inherent pitavastatin and pitavastatin lactone, one of the metabolites. On day 6, 2 mg/kg of CsA was administered 1 hour before the application of pitavastatin, and then the blood samples were collected. After the co-administration of CsA, the plasma concentrations of inherent pitavastatin showed a marked increase. Of parameters of inherent pitavastatin pharmacokinetics (PK), mean values of maximum concentration of the drug (Cmax) and area under the concentration vs. time curve (AUC0-24) reached 6.58-(range: 4.43-10.36) and 4.55-(range: 3.93-5.86) fold increases, respectively. Time to reach Cmax (tmax) and elimination half-life time (t1/2) were hardly affected. On the other hand, no significant changes were observed in the plasma concentrations of pitavastatin lactone and the blood concentrations of CsA. These results suggest that plasma concentration of pitavastatin increases due to the drug-drug interaction with CsA and careful observation should be taken about PK change of pitavastatin in the case of the co-administration with CsA. (author abst.) |
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