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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

Page last updated: August 23, 2015

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