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Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

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ClinicalTrials.gov Identifier: NCT01552850
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pain Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Oxycodone Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : April 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

Additional Information:
Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT01552850     History of Changes
Other Study ID Numbers: B4501010
First Posted: March 13, 2012    Key Record Dates
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