NCT00878072

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

A Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Uncontrolled study

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	Famciclovir	Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.

Timeline

• Start date: 2009-03-25
• Primary completion: 2010-06-02
• Completion: 2010-06-02
• First posted: 2009-04-08
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

12 sites across 1 country: United States