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

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

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

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