NCT00762749

Study to Evaluate Diphenhydramine in Children and Adolescents

An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Diphenhydramine 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 diphenhydramine 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. Twenty-four (24) children, ages 2 to \< 12 years, and 12 adolescents, ages 12 to \< 18 years, with 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 children enrolled will range from 2 to \< 6 years of age.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	diphenhydramine HCl	A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight 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