A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
- Registration Number
- NCT00297206
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 4 Valaciclovir Subjects in the age group of 3 months to less than 6 months will be included Cohort 3 Valaciclovir Subjects in the age group of 6 months to less than 1 year will be included Cohort 1 Valaciclovir Subjects in the age group of 2 to less than 6 years will be included Cohort 2 Valaciclovir Subjects in the age group of 1 to less than 2 years will be included Cohort 5 Valaciclovir Subjects in the age group of 1 month to less than 3 months will be included
- Primary Outcome Measures
Name Time Method Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose. 0.5, 1, 2, 4 and 6 hours
- Secondary Outcome Measures
Name Time Method Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication. Up to Day 5
Trial Locations
- Locations (1)
GSK Investigational Site
πΏπ¦George, South Africa