NCT00297206

A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 1 Month – 6 Years
• Healthy volunteers: Not accepted

Summary

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	Valaciclovir	Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.

Timeline

• Start date: 2003-01-25
• Primary completion: 2007-02-28
• Completion: 2007-02-28
• First posted: 2006-02-28
• Last updated: 2017-09-11

Locations

13 sites across 3 countries: United States, Chile, South Africa