ISSN:
1432-1041
Keywords:
Key words ABT-761
;
Pharmacokinetics
;
Asthma
Source:
Springer Online Journal Archives 1860-2000
Topics:
Chemistry and Pharmacology
,
Medicine
Notes:
Abstract Objective: The pharmacokinetics of an N-hydroxyurea analog, ABT-761 in asthmatic pediatric patients with asthma were investigated. Methods: A total of 24 patients were enrolled into this 8-day single- and multiple-dose study. Patients received daily doses of ABT-761 according to their body weight: patients of 20–38 kg received 50 mg; patients 〉38 kg but ≤55 kg received 100 mg, and patients ≥55 kg received 150 mg. Results: The mean values for the terminal phase t1/2 were 16–17 h after multiple-dose administration. When normalized for body weight, the mean day 8 Clf values for 50-, 100-mg, and 150-mg doses were 0.57 (n = 13), 0.51 (n = 10), and 0.43 (n = 1) ml · min−1 · kg−1, respectively, while the mean Vz/f values ranged from 0.75 to 0.77 l · kg−1. The mean accumulation ratio observed (day 8 to day 1 AUC0–24 ratio) of ABT-761 was approximately 1.7, which is consistent with the t1/2 of this drug. Body weight, age, and body surface area were virtually identical in explaining the variability in dose-normalized Cmax and AUC values (R 2 = 0.61–0.68). The percents of variance explained by these three variables were within a range of 3% for each pharmacokinetic parameter. Conclusions: The pharmacokinetics of ABT-761 in children were similar to those previously reported in adults. Body weight, age, or body surface area can be used to provide dosing adjustment for ABT-761 in pediatric patients.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/s002280050540
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