Pharmacokinetics of Valacyclovir Oral Solution in Children
- Sponsor
- Radboud University Medical Center
- Study ID
- NCT04081480
- Status
- Terminated
Conditions
- Herpes Simplex Virus Infection
- Varicella Zoster Virus Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- Valacyclovir — DRUGPK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
Study Details
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.
Key Dates
- Start date
- Dec 10, 2019
- Status verified
- Jun 2021
- Primary completion
- May 12, 2021
- Completion
- May 12, 2021
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Other: Valacyclovir oral solutionValacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more.
Primary Outcome Measure
Area under the curve [ Time Frame: 12 hours ]