Phenylephrine Pediatric Pharmacokinetic Study

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Rhinitis

Clinical Trial Details

NCT number	NCT00762567
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Completed
Phase	Phase 1
Start date	September 2008
Completion date	November 2008

View Details

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