A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) 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 controlled-release test formulation (Drug); Immediate-release reference drug (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 determine whether the bioavailability of the controlled-release test formulation is at
least as high as that for the commercial reference drug.
Clinical Details
Official title: An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
Study design: Observational Model: Case-Crossover, Time Perspective: Prospective
Primary outcome: pharmacokinetic endpoints - area under the concentration curve (AUC)
Secondary outcome: Peak concentration (Cmax) and time to peak concentration (Tmax)
Detailed description:
Serial sampling of venous blood
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy volunteers, greater than 50 kg, able and willing to sign informed consent
Exclusion Criteria:
- Evidence of significant illness, condition affecting drug absorption, history of
sleep apnea, and allergy to opioid drugs
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: September 2012
Last updated: October 22, 2012
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