A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01530542 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : February 24, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Analgesia Acute Pain Chronic Pain Narcotic Abuse Opioid-related Disorders | Drug: oxycodone hydrochloride Drug: marketed oxycodone hydrochloride | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment A |
Drug: oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions |
Experimental: Treatment B |
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions |
Experimental: Treatment C |
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions |
Experimental: Treatment D |
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions |
Experimental: Treatment E |
Drug: marketed oxycodone hydrochloride
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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530542
United States, Texas | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78217 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01530542 |
Other Study ID Numbers: |
K234-10-1001 B4501006 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | February 24, 2012 |
Last Verified: | February 2012 |
bioavailability food effect oxycodone management of acute and chronic moderate to severe pain |
Chronic Pain Acute Pain Opioid-Related Disorders Pain Neurologic Manifestations Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |