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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 25, 2003

Primary Completion Date

February 28, 2007

Study Completion Date

February 28, 2007

Conditions
Herpes Simplex
Interventions
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.

Trial Locations (13)

2000

GSK Investigational Site, Brits

6529

GSK Investigational Site, George

27705

GSK Investigational Site, Durham

32209

GSK Investigational Site, Jacksonville

35233

GSK Investigational Site, Birmingham

40202

GSK Investigational Site, Louisville

40503

GSK Investigational Site, Lexington

45229

GSK Investigational Site, Cincinnati

70112

GSK Investigational Site, New Orleans

72202

GSK Investigational Site, Little Rock

92123

GSK Investigational Site, San Diego

7580206

GSK Investigational Site, Santiago

77555-0653

GSK Investigational Site, Galveston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00297206 - A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children | Biotech Hunter | Biotech Hunter