Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00796315
Study type	Interventional
Source	Procter and Gamble
Contact
Status	Completed
Phase	Phase 1
Start date	December 2008
Completion date	June 2009

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