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Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

NCT00796315 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-02-04

Study results available
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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.

Conditions

  • Allergic Rhinitis
  • Upper Respiratory Infection

Interventions

DRUG

Doxylamine Succinate USP

One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL

Sponsors & Collaborators

  • Consumer Healthcare Products Association

    collaborator OTHER

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Molly Seeck, BS, JD · Procter and Gamble

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796315 on ClinicalTrials.gov