Overview

Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Procter and Gamble
Collaborator:
Consumer Healthcare Products Association
Treatments:
Doxylamine
Doxylamine succinate