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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01476215
The ClinicalTrials.gov registry entry for NCT01476215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Paracetamol is the first listed.
NCT01476215 reports 0 study locations.
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.
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