At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
Doxylamine Succinate USPdrug
Likely dose
Doxylamine Succinate USP 3.125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-dose, Open-label, Multi-center Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Ages 2 to < 18 Years
In Brief
A Phase 1 clinical trial evaluating Doxylamine Succinate USP for Allergic Rhinitis and Upper Respiratory Infection. Completed, enrolled 41 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Upper Respiratory Infection
CountriesUnited States
CollaboratorsConsumer Healthcare Products Association
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartDec 2008
Primary CompletionJun 2009
TodayJul 2026
First PostedNov 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.6 years ago
Interventions
Doxylamine Succinate USPdrug
One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL