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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 19 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01677039
The ClinicalTrials.gov registry entry for NCT01677039 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Test formulation administered with water is the first listed.
NCT01677039 reports 0 study locations.
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.
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