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Effect of severe renal impairment on the pharmacokinetics of azimilide following single dose oral administration
Author(s) -
Corey Alfred E.,
Agnew Jeffrey R.,
Valentine Suzanne N.,
Parekh Nikhil J.,
Powell James H.,
Thompson Gary A.
Publication year - 2002
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.2002.01664.x
Subject(s) - medicine , pharmacokinetics , confidence interval , renal function , oral administration , urology , urine , anesthesia
Aims To assess the influence of severe renal impairment on azimilide pharmacokinetics. Methods A single oral dose of 125 mg azimilide dihydrochloride was administered to subjects with normal and severely impaired renal function. Blood and urine samples were collected for 22–28 and 10 days, respectively. Results Azimilide renal clearance decreased in subjects with renal impairment (mean 14 vs 4.8 ml h −1 kg −1 , 95% confidence interval on the ratio 0.23, 0.50). However, no change in any other pharmacokinetic parameter including oral clearance (mean 109 vs 104 ml h −1 kg −1 , 95% confidence interval on the ratio 0.67, 1.36) was observed. Conclusions Since azimilide blood concentrations are essentially unaffected by renal function, an a priori dosage regimen adjustment is not required in patients with renal impairment.