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NCT02117583 · ClinicalTrials.gov registry record · Phase 1
Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Pain Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 2
- Study locations
NCT02117583: Completed Phase 1 study of Healthy, sponsored by Pain Therapeutics.
NCT02117583 is a Phase 1 study of Healthy that has completed, run by Pain Therapeutics. The registered enrollment target is 34 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117583, a Phase 1 study of Healthy, has completed, sponsored by Pain Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 2
- Study locations
Study Summary
To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.
Primary Outcome
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Conditions Studied
Interventions
- DRUG Oxycodone
Study Locations (2)
Kansas
- Pfizer Investigational Site - Overland Park
- Pfizer Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02117583 record still lists
NCT02117583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Oxycodone is the first listed.
NCT02117583 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02117583 about?
NCT02117583 is a clinical study titled "Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers". To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this cro...
What is the current status of trial NCT02117583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2014-04. Estimated completion is 2014-08.
What conditions does trial NCT02117583 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02117583?
The interventions under investigation include: Oxycodone (DRUG).
Who is sponsoring clinical trial NCT02117583?
This trial is sponsored by Pain Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02117583 being conducted?
This trial has 2 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02117583's enrollment target sits among peer trials
34 631st of 1090 higher than 451 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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