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Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01717027
First received: October 26, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers


Condition Intervention Phase
Healthy
 Drug: Oxycodone
 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, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Concentration at time 24 hours (C24) of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
 Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions
Experimental: Treatment B
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
 Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions
Experimental: Treatment C
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
 Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions
Experimental: Treatment D
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
 Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted 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 and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Positive urine drug test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717027

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01717027     History of Changes
Other Study ID Numbers: B4501034
Study First Received: October 26, 2012
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics
bioavailability
oxycodone
management of moderate to severe pain

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013