Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing. The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir. Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
7
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Prinses Maxima Centrum voor kinderoncologie
Utrecht, Netherlands
Area under the curve
Acyclovir area under the curve (12h)
Time frame: 12 hours
Cmax
Maximum concentration of aciclovir
Time frame: 12 hours
Tmax
Time to reach maximum concentration of aciclovir
Time frame: 12 hours
Number of adverse events
Number of adverse events
Time frame: 1 day
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