drugset / Trial / NCT00796315

Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

NCT00796315

NaSingle-groupOpen-label

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.

Timeline

Start
2008-12
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxylamine Small molecule 3.125 mg
Subject Doxylamine Small molecule 12.5 mg