Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
- Registration Number
- NCT02059915
- Lead Sponsor
- Pain Therapeutics
- Brief Summary
To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
- Healthy male and/or female subjects between 18 and 55 years of age
Exclusion Criteria
- Evidence or history of clinically significant disease.
- Positive urine drug test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment D Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment A Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment B Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax) 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
- Secondary Outcome Measures
Name Time Method Plasma Decay Half-Life (t1/2) 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Concentration at time 24 hours (C24) 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 Time to Reach Maximum Observed Plasma Concentration (Tmax) 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸St. Paul, Minnesota, United States