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

NCT01689285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-12-08

No results posted yet for this study

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.

Conditions

  • Varicella Zoster Virus Infection
  • Herpes Simplex Virus Infection

Interventions

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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Bas Schouwenberg, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689285 on ClinicalTrials.gov