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Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

NCT00878072 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-06-25

Study results available
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Summary

This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose

Conditions

  • Herpes Labialis

Interventions

DRUG

Famciclovir

Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-25
Primary Completion
2010-06-02
Completion
2010-06-02

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00878072 on ClinicalTrials.gov