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NCT01456507 · ClinicalTrials.gov registry record · Phase 1
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01456507: Completed Phase 1 study, sponsored by Pfizer.
NCT01456507 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456507, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Interventions
- DRUG ALO-02 (Oxycodone Naltrexone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01456507 record still lists
NCT01456507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which ALO-02 (Oxycodone Naltrexone) is the first listed.
NCT01456507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01456507 about?
NCT01456507 is a clinical study titled "Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone". The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
What is the current status of trial NCT01456507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-10. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01456507?
The interventions under investigation include: ALO-02 (Oxycodone Naltrexone) (DRUG).
Who is sponsoring clinical trial NCT01456507?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01456507's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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