To characterize the pharmacokinetics of diphenhydramine in two pediatric populations: children, ages 2 to \< 12 years, and adolescents, ages 12 to \< 18 years.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
A single liquid dose of diphenhydramine HCl (12.5 mg /5 mL) followed by water, according to an age-weight dosing schedule
Arkansas Medical Research Testing Center
Little Rock, Arkansas, United States
Pharmacokinetic parameters
Time frame: predose (0), and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, and 24 hours after the dose
Safety Assessments will consist of monitoring vital signs and all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study + 2 days (+ 30 days for spontaneously reported SAEs)
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