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NCT00796315 · ClinicalTrials.gov registry record · Phase 1

Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children

A Phase 1 study, sponsored by Procter and Gamble.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT00796315 is a Phase 1 study that has completed, run by Procter and Gamble. The registered enrollment target is 41 participants.

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The verdict

NCT00796315, a Phase 1 study, has completed, sponsored by Procter and Gamble.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study 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.

Interventions

  • DRUG Doxylamine Succinate USP

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2008-12
Est. Completion 2009-06
Phase Phase 1

Sponsor

Procter and Gamble

70 total trials

What the Registry Record Tells You About NCT00796315

The ClinicalTrials.gov registry entry for NCT00796315 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Procter and Gamble, which has 70 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Doxylamine Succinate USP is the first listed.

NCT00796315 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00796315 about?

NCT00796315 is a clinical study titled "Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children". 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 (...

What is the current status of trial NCT00796315?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2008-12. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00796315?

The interventions under investigation include: Doxylamine Succinate USP (DRUG).

Who is sponsoring clinical trial NCT00796315?

This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.