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NCT01677039 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01677039: Completed Phase 1 study, sponsored by Pfizer.
NCT01677039 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677039, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
Interventions
- DRUG Test formulation administered with water
- DRUG Test formulation administered with 20% ethanol
- DRUG Test formulation administered with 40% ethanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01677039 record still lists
NCT01677039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Test formulation administered with water is the first listed.
NCT01677039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01677039 about?
NCT01677039 is a clinical study titled "Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation". The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary p...
What is the current status of trial NCT01677039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01677039?
The interventions under investigation include: Test formulation administered with water (DRUG), Test formulation administered with 20% ethanol (DRUG), Test formulation administered with 40% ethanol (DRUG).
Who is sponsoring clinical trial NCT01677039?
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 NCT01677039's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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