drugset / Trial / NCT04081480

Pharmacokinetics of Valacyclovir Oral Solution in Children

NCT04081480

Terminated 7 enrolled Radboud University Medical Center
NaSingle-groupOpen-labelOther

Summary

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.

Timeline

Start
2019-12-10
Primary completion
2021-05-12
Completion
2021-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Valacyclovir Unknown 10 mg/kg Oral
Subject Valacyclovir Unknown 500 mg Oral