Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders
Conditions
Keywords
bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain
Brief summary
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.
Interventions
oxycodone hydrochloride 5 mg tablet under fasted conditions
DRUGmarketed oxycodone hydrochloride
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects between 18 and 55 years of age (inclusive)
Exclusion criteria
* Evidence or history of clinically significant disease; * History of obstructive sleep apnea; * Positive urine drug test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 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) | 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) | 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) | 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 - ∞)] | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to each Post-Dose Assessment in Respiratory Rate | 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, %) | 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. |
| Change from Screening to End-of-Study Assessment in Hematology Parameters | Screening up to approximately 3 months |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Screening up to approximately 3 months |
| Change from Screening to End-of-Study Assessment in Urinalysis Parameters | Screening up to approximately 3 months |
| Change from Screening to End-of-Study Assessment in ECG Measurements | Screening up to approximately 3 months |
| Change from Screening to End-of-Study Assessment in Chemistry Parameters | Screening up to approximately 3 months |
| Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Screening up to approximately 3 months |
| Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment | 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 | 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. |
| Change from Baseline to each Post-Dose Assessment in Heart Rate | 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. |
Countries
United States
Outcome results
None listed