NCT02165930CompletedPhase 1
An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pain Therapeutics
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Study Overview
Brief Summary
To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers
- •History of moderate alcohol consumption
- •Total body weight exceeding 64 kg
Exclusion Criteria
- •Evidence or history of clinically significant disease.
- •Positive urine drug test
- •History of alcoholism or heavy alcohol consumption
Arms & Interventions
Treatment B
Experimental
Intervention: Naltrexone (Drug)
Treatment B
Experimental
Intervention: Oxycodone (Drug)
Treatment A
Experimental
Intervention: Naltrexone (Drug)
Treatment A
Experimental
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
- 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)
- Plasma Decay Half-Life (t1/2)(0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48)
Investigators
Study Sites (1)
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