Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir — VALID-I

Herpes Simplex Virus Infection Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01689285
Study type	Interventional
Source	Radboud University
Contact
Status	Completed
Phase	Phase 1
Start date	December 2013
Completion date	July 2015

View Details

See also
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