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The Effects of Multiple Doses of Fenofibrate on the Pharmacokinetics of Pravastatin and Its 3-Hydroxy Isomeric Metabolite

From the Departments of Clinical Pharmacokinetics (Dr Gustavson, Ms Schweitzer) and Clinical Pharmacology (Dr Achari, Mr Chira), the TriCor Global Project Team (Dr Yannicelli), Abbott Laboratories, Abbott Park, Illinois, and the Departments of Statistics (Mr Koehne-Voss) and Clinical Pharmacology (Dr Esslinger), Abbott Laboratories, Ludwigshafen, Germany.

Published data indicate that coadministration of multiple doses of the fibrate drug, gemfibrozil, led to a 202% increase in pravastatin systemic exposure (area under the plasma concentration-time curve, AUC). To evaluate the effects of another fibrate drug, fenofibrate, on the pharmacokinetics of pravastatin, 24 healthy subjects took pravastatin (40 mg once daily) on study days 1 to 15 and fenofibrate (160 mg once daily) on study days 6 to 15. Blood samples were collected for 24 hours after dosing on days 5, 6, and 15. Plasma concentrations of pravastatin and its active metabolite, 3-hydroxy-iso-pravastatin, were measured, and pharmacokinetics was assessed. Safety assessments were based on adverse events, physical examinations, electrocardiogram results, vital signs, and clinical laboratory testing. Safety results were unremarkable. Coadministration of fenofibrate had modest effects on pravastatin and 3-hydroxy-iso-pravastatin systemic exposures (AUC). Increases in pravastatin systemic exposures (19%-28%, on average) and 3-hydroxy-iso-pravastatin systemic exposures (24%-39%, on average) were observed upon coadministration, but individual changes were variable. Pravastatin and 3-hydroxy-iso-pravastatin systemic exposures were not statistically significantly different following the 1st and 10th doses of fenofibrate.

Key Words: Fenofibrate • 3-hydroxy-iso-pravastatin • pravastatin • pharmacokinetics • drug interactions

Address for reprints: Linda E. Gustavson, PhD, Abbott Laboratories, Deptartment R4PK, Building AP13A, 100 Abbott Park Road, Abbott Park, IL 60064-6104.

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