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Effect of Age and Gender on Azimilide Pharmacokinetics After a Single Oral Dose of Azimilide Dihydrochloride
Author(s) -
Corey Alfred,
Agnew Jeffrey,
Bao James,
Bryson Philip,
Comer Patrick,
Griffith Susan,
Li Junfang
Publication year - 1997
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1997.tb04269.x
Subject(s) - pharmacokinetics , medicine , dosing , oral administration , anesthesia , pharmacology
Azimilide is a new class III antiarrhythmic drug that blocks K + channels. To determine the effects of age and gender on azimilide pharmacokinetics, a single 150‐mg oral dose was administered to 66 healthy volunteers in a 3 × 2 factorial design (age groups of 18–40, 41–64, and ≥65 years). Blood and urine were analyzed for azimilide and metabolites. The single dose was well‐tolerated. Azimilide was 94% plasma protein bound, and binding was not affected by age or gender. Age does not affect azimilide pharmacokinetics. The renal clearance of azimilide was significantly higher in women than in men (19%), but oral clearance did not differ between genders. Although the maximum azimilide concentration (C max ) was 27% higher in women, time to maximum concentration or area under the azimilide concentration—time curve were not different from those for men. Body weight—adjusted C max did not differ between genders. Dosing adjustments based on either age or gender are not required . J Clin Pharmacol 1997;37:946–953.