NCT00762567

Phenylephrine Pediatric Pharmacokinetic Study

An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to \<12 years, and adolescents, ages 12 to \<18 years.

Detailed description

This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to \<12 years, and twelve (12) adolescents, ages 12 to \<18 years, with nasal symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the 24 children enrolled will range from 2 to \<6 years of age.

Conditions

• Rhinitis

Interventions

Type	Name	Description
DRUG	phenylephrine HCl	A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-09-30
• Last updated: 2011-10-06

Locations

1 site across 1 country: United States