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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


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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