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| ID | Type | Description | Link |
|---|---|---|---|
| B4501006 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
| |
| Treatment C | Experimental |
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| Treatment D | Experimental |
| |
| Treatment E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxycodone hydrochloride | Drug | oxycodone hydrochloride 5 mg tablet under fasted conditions |
| |
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | San Antonio | Texas | 78217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22717418 | Derived | Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| oxycodone hydrochloride |
| Drug |
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions |
|
| oxycodone hydrochloride | Drug | 2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions |
|
| oxycodone hydrochloride | Drug | 2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions |
|
| marketed oxycodone hydrochloride | Drug | 1 x oxycodone hydrochloride 15 mg tablet under fed conditions |
|
| 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. |
| 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 |
| Change from Screening to End-of-Study Assessment in Chemistry Parameters | 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 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D000079524 | Narcotic-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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