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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01530542
First received: January 18, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Analgesia
Acute Pain
Chronic Pain
Narcotic Abuse
Opioid-related Disorders
Drug: oxycodone hydrochloride
Drug: marketed oxycodone hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Change from Screening to End-of-Study Assessment in Hematology Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
  • Change from Screening to End-of-Study Assessment in Chemistry Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
  • Change from Screening to End-of-Study Assessment in Urinalysis Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
  • Change from Screening to End-of-Study Assessment in ECG Measurements [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: July 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530542

Locations
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01530542     History of Changes
Other Study ID Numbers: K234-10-1001, B4501006
Study First Received: January 18, 2012
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Adminstration

Keywords provided by Pfizer:
bioavailability
food effect
oxycodone
management of acute and chronic moderate to severe pain

Additional relevant MeSH terms:
Acute Pain
Chronic Pain
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Substance-Related Disorders
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014