A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Management of Moderate to Severe Pain
Intervention: Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This is an open-label (both the physician and healthy volunteer know which medication will
be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics
of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and
eliminated by the body). This study will consist of three parts that will take place over
approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have
one dosing period each.
Clinical Details
Official title: Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]Maximum Observed Plasma Concentration (Cmax)
Secondary outcome: Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment EArea Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) Plasma Concentration 24 Hours Post-Dose (C24) Time to Reach Maximum Observed Plasma Concentration (Tmax) Plasma Decay Half-Life (t1/2)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
- History of obstructive sleep apnea.
- Positive urine drug test.
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2012
Last updated: October 8, 2012
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