Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01552850
First received: March 9, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution


Condition Intervention Phase
Management of Moderate to Severe Pain
Drug: Oxycodone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers

Resource links provided by NLM:


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 ]
  • Adverse events, vital signs and laboratory parameters. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone Formulation A Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Drug: Oxycodone
1X40 mg PF-00345439 formulation A capsule with water and under fed condition
Experimental: Oxycodone Formulation B Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Drug: Oxycodone
1X40 mg PF-00345439 formulation B capsule with water and under fed condition
Experimental: Oxycodone Formulation C Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Drug: Oxycodone
1X40 mg PF-00345439 formulation C capsule with water and under fed condition
Experimental: Oxycodone Formulation D Capsule
single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Drug: Oxycodone
1X40 mg PF-00345439 formulation D capsule with water and under fed condition
Experimental: Oxycodone Oral Solution
40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block
Drug: Oxycodone
40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552850

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01552850     History of Changes
Other Study ID Numbers: B4501010
Study First Received: March 9, 2012
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics
relative bioavailability
oxycodone

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 April 22, 2014