NCT00796315

Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

A Single-dose, Open-label, Multi-center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergic Rhinitis
• Upper Respiratory Infection

Interventions

Type	Name	Description
DRUG	Doxylamine Succinate USP	One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-11-24
• Last updated: 2013-02-04
• Results posted: 2013-01-25

Locations

6 sites across 1 country: United States