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
Completed
- Conditions
- Healthy
- Interventions
- Drug: Immediate-release reference drug
- Registration Number
- NCT01677065
- Lead Sponsor
- Pfizer
- Brief Summary
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
- Detailed Description
Serial sampling of venous blood
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment A Oxycodone controlled-release test formulation Controlled release oxycodone test formulation 40 mg Treatment B Immediate-release reference drug Immediate release oxycodone reference drug 20 mg
- Primary Outcome Measures
Name Time Method pharmacokinetic endpoints - area under the concentration curve (AUC) 0-48 hr
- Secondary Outcome Measures
Name Time Method Peak concentration (Cmax) and time to peak concentration (Tmax) 0-48 hr
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States