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A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530542
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]
  2. Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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. ]
  8. Change from Screening to End-of-Study Assessment in Hematology Parameters [ Time Frame: Screening up to approximately 3 months ]
  9. Change from Screening to End-of-Study Assessment in Chemistry Parameters [ Time Frame: Screening up to approximately 3 months ]
  10. Change from Screening to End-of-Study Assessment in Urinalysis Parameters [ Time Frame: Screening up to approximately 3 months ]
  11. Change from Screening to End-of-Study Assessment in ECG Measurements [ Time Frame: Screening up to approximately 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Pfizer:
bioavailability
food effect
oxycodone
management of acute and chronic moderate to severe pain
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
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