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
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 9/30/2018 |
| Start Date: | September 2012 |
| End Date: | October 2012 |
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.
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
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