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NCT01476215 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01476215: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01476215 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01476215, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
Interventions
- DRUG Paracetamol
- DRUG Paracetamol fast dissolution suspension
- DRUG Paracetamol medium dissolution suspension
- DRUG Paracetamol slow dissolution suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-11 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
What the finished NCT01476215 record still lists
NCT01476215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Paracetamol is the first listed.
NCT01476215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01476215 about?
NCT01476215 is a clinical study titled "A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions". This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
What is the current status of trial NCT01476215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-11. Estimated completion is 2009-11.
What interventions are being tested in trial NCT01476215?
The interventions under investigation include: Paracetamol (DRUG), Paracetamol fast dissolution suspension (DRUG), Paracetamol medium dissolution suspension (DRUG), Paracetamol slow dissolution suspension (DRUG).
Who is sponsoring clinical trial NCT01476215?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01476215's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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