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Study to Evaluate Diphenhydramine in Children and Adolescents

NCT00762749 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-10-06

No results posted yet for this study

Summary

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

Conditions

  • Allergic Rhinitis

Interventions

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

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Cathy M Gelotte, PhD · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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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 NCT00762749 on ClinicalTrials.gov