EFFECT OF AGE AND GENDER ON AZIMILIDE PHARMACOKINETICS AFTER A SINGLEORAL DOSE OF AZIMILIDE DIHYDROCHLORIDE

Azimilide is a new class III antiarrhythmic drug that blocks K+ channe ls. To determine the effects of age and gender on azimilide pharmacoki netics, a single 150-mg oral dose was administered to 66 healthy volun teers in a 3 X 2 factorial design (age groups of 18-40, 41-64, and gre ater than or equal to 65 years). Blood and urine were analyzed for azi milide and metabolites. The single dose was well-tolerated. Azimilide was 94% plasma protein-bound, and binding was not affected by age or g ender. Age does not affect azimilide pharmacokinetics. The renal clear ance of azimilide was significantly higher in women than in men (19%), but oral clearance did not differ between genders. Although the maxim um azimilide concentration (C-max) was 27% higher in women, time to ma ximum concentration or area under the azimilide concentration-time cur ve were not different from those for men. Body weight-adjusted C-max d id not differ between genders. Dosing adjustments based on either age or gender are not required.