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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: Completed Phase 1 study, sponsored by Procter and Gamble.
NCT00796315 is a Phase 1 study that has completed, run by Procter and Gamble. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.
Interventions
- DRUG Doxylamine Succinate USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
What the finished NCT00796315 record still lists
NCT00796315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which Doxylamine Succinate USP is the first listed.
NCT00796315 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00796315's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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