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

Pfizer14 enrolled

Overview

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Serial sampling of venous blood

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Interventions

Oxycodone controlled-release test formulationDRUG

single dose administration of test formulation under fasted conditions

Immediate-release reference drugDRUG

single dose administration of reference drug under fasted conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

pharmacokinetic endpoints - area under the concentration curve (AUC)

Time frame: 0-48 hr

Secondary Outcomes

Peak concentration (Cmax) and time to peak concentration (Tmax)

Time frame: 0-48 hr

Data from ClinicalTrials.gov

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