Lack of pharmacokinetic interaction between anidulafungin and tacrolimus

被引:45
作者
Dowell, James A.
Stogniew, Martin
Krause, David
Henkel, Timothv
Damle, Bharat
机构
[1] Pfizer Inc, Clin Pharmacol, Pfizer Global Res & Dev, New York, NY 10017 USA
[2] Pfizer Inc, Vicuron Pharmaceut, New York, NY 10017 USA
关键词
anidulafungin; tacrolimus; drug interaction; pharmacokinetics; tolerability;
D O I
10.1177/0091270006296764
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The safety and pharmacokinetics of anidulafungin coadministered with tacrolimus were investigated using a single-sequence, open-label design. Healthy volunteers received 5 mg tacrolimus orally on days 1 and 13 of the study. Anidulafungin (200 mg) was administered intravenously on day 4, followed by 100-mg doses on days 5 through 13, Key pharmacokinetic parameters, including C-max, AUC, t(1/2), CL, and V-ss, were derived from concentration-time data. The 90% confidence intervals (CIs) of the ratios of mean pharmacokinetic parameters of anidulafungin plus tacrolimus to each drug alone were well within the 80% to 125% bioequivalence range, indicating no pharmacokinetic interaction. This ratio was 101.6 (90% CI: 92.77-111.22) for tacrolimus AUC(0-infinity) and 107.2 (90% CI: 105.1-109.4) for anidulafungin AUC(ss). The 2 drugs were well tolerated, and no drug-related serious adverse events were reported. Because of its lack of pharmacokinetic interaction with key immunosuppressive agents, anidulufungin is an important option for the prevention and treatment of invasive fungal infections in transplant recipients.
引用
收藏
页码:305 / 314
页数:10
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