NCT01689285

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of VZV and HSV Infections in Children, Phase I (VALID-I)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.

Detailed description

Bioequivalence of the new valcyclovir formulation will be tested according to the EMA guideline for bioequivalence.

Conditions

• Varicella Zoster Virus Infection
• Herpes Simplex Virus Infection

Interventions

Type	Name	Description
DRUG	valacyclovir tablet	16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
DRUG	valacyclovir oral solution	16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-09-21
• Last updated: 2020-12-08

Locations

1 site across 1 country: Netherlands