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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
35
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
Pfizer Investigational Site
San Antonio, Texas, United States
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
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