Conditions: Allergic Rhinitis Upper Respiratory Infection
Keywords: Pharmacokinetic study
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: yes

Brief summary:
The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to \< 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.

Detailed description:

Arms:
arm 1: Doxylamine Succinate United States Pharmacopeia (USP)

Interventions: intervention 1: Doxylamine Succinate USP
Intervention descriptions: intervention 1: One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL

Protocol document: