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Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552850
First Posted: March 13, 2012
Last Update Posted: August 31, 2015
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.
Information provided by (Responsible Party):
Pain Therapeutics
  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
Pain Drug: Oxycodone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Pain Therapeutics:

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 ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Detailed Description:
This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01552850


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

Additional Information:
Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT01552850     History of Changes
Other Study ID Numbers: B4501010
First Submitted: March 9, 2012
First Posted: March 13, 2012
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Pain Therapeutics:
pharmacokinetics
relative bioavailability
oxycodone

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