Effects of red &white wine on cytochrome p450 3A4 activity in healthy individual

$0M01FY2000RRNIH

Tufts Medical Center, Boston MA

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Abstract

Our recent study found that red wine causes significant decreases in cyclosporine exposure. This study will determine if white wine also affects cyclosporine pharmacokinetics. In addition, we will investigate the effect of continuous dosing of red and white wine on cyclosporine disposition. This study will investigate twenty-four healthy volunteers in a randomized, two-arm study. Subjects will be randomized to group A (white wine) or Group B (red wine). A single 8 mg/kg oral dose of cyclosporine will be given with water and white or red wine on separate occasions and blood will be drawn over 24 hours for a pharmacokinetic profile. Subjects will then consume a 12 oz glass of white or red wine once a day for 7 days and a pharmacokinetic profile will be obtained. Whole blood levels will be analyzed by a specific fluorescence polarization immunoassay; and the pharmacokinetics of cyclosporine will be compared both within and between groups.

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