A Phase 1 interventional study of oxycodone hydrochloride and oxycodone hydrochloride in Analgesia, Acute Pain and Chronic Pain, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-24.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: oxycodone hydrochloride
Drug: oxycodone hydrochloride
Drug: oxycodone hydrochloride
Drug: oxycodone hydrochloride
Drug: marketed oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area under the Concentration-Time Curve (AUC)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to approximately 3 months
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to approximately 3 months
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Heart Rate
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Respiratory Rate
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
Time frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Screening to End-of-Study Assessment in Hematology Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Time frame: Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in ECG Measurements
Time frame: Screening up to approximately 3 months
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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