Study of the pharmacokinetics of the antiarrhythmic drug sotalol in pediatric patients age newborn to 12 years. Sotalol has been widely used in pediatrics for rhythm control, but its pharmacokinetics has not been studied. The study will be a multi-center, open-label, one period, single dose pharmacokinetic study. The study will collect pharmacokinetic information from pediatric patients of different age groups after a single dose of sotalol solution. The study is to support the derivation of an appropriate dosage regimen for pediatric use of sotalol.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR002172-18
Application #
6418628
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1983-01-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
18
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115
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