Food Effect And Relative Bioavailability Study 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: Healthy
Intervention: 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
To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg
doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to
PF-00345439 Formulation X in the fasted state in healthy volunteers
Clinical Details
Official title: An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State 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 - 8)]Maximum Observed Plasma Concentration (Cmax)
Secondary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)Concentration at time 24 hours (C24) of oxycodone, as data permit. 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
- Positive urine drug test
Locations and Contacts
Pfizer Investigational Site, Baltimore, Maryland 21225, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2013
Last updated: October 25, 2013
|