An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pain Therapeutics
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Treatment A
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).
Intervention: Oxycodone (Drug)
Treatment B
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).
Intervention: Oxycodone (Drug)
Treatment C
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).
Intervention: Oxycodone (Drug)
Treatment D
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).
Intervention: Oxycodone (Drug)
Outcomes
Primary Outcomes
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: 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)
Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Secondary Outcomes
- 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)
- 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)