Pharmacokinetics of Valsartan in Pediatric and Adolescent Subjects With Hypertension

An open-label, single-dose study is conducted in 26 children with hypertension to characterize the pharmacokinetics of valsartan. Valsartan is administered as an oral suspension (dose of 2 mg/kg), with the maximum single dose being 80 mg. Subjects are stratified into 4 age categories: group 1, 1 to less than 4 years; group 2, 4 to less than 6 years; group 3, 6 to less than 12 years; group 4, 12 to 16 years. Blood samples are collected before and for 24 hours after dosing to quantitate valsartan. Because the body weight of most children in groups 3 and 4 exceeds 40 kg and they received a dose of less than 2 mg/kg, major pharmacokinetic parameters are dose normalized for comparison across the age groups. Dose-normalized maximum plasma concentration and area under the plasma-concentration curve and body weight—normalized apparent oral clearance are comparable for the 4 groups (P ≥ .1011). Body weight—normalized apparent oral clearance ranges from 0.061 to 0.089 L/h/kg.