This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Tokyo, Japan
AUC of valsartan in plasma
Time frame: Up to 24 hours post-dose
Cmax of valsartan in plasma
Time frame: Up to 24 hours post-dose
Tmax of valsartan in plasma
Time frame: Up to 24 hours post-dose
T1/2 of valsartan in plasma
Time frame: Up to 24 hours post-dose
CL/F of valsartan in plasma
Time frame: Up to 24 hours post-dose
ECG evaluations
Time frame: 24 hours post-dose
Standard clinical laboratory evaluations
Time frame: 24 hours post-dose
Vital signs
Time frame: 2, 4, and 24 hours post-dose
Physical examination
Time frame: 24 hours post-dose
Number and severity of adverse events
Time frame: Up to 24 hours post-dose
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