Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

Study Overview
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Brief Summary
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To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution

Detailed Description
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This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.

Official Title
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An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive Exclusion Criteria: Evidence or history of clinically significant diseases

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone Formulation A Capsule<br>single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block | Drug: Oxycodone<br>* 1X40 mg PF-00345439 formulation A capsule with water and under fed condition<br>|
| Experimental: Oxycodone Formulation B Capsule<br>single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block | Drug: Oxycodone<br>* 1X40 mg PF-00345439 formulation B capsule with water and under fed condition<br>|
| Experimental: Oxycodone Formulation C Capsule<br>single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block | Drug: Oxycodone<br>* 1X40 mg PF-00345439 formulation C capsule with water and under fed condition<br>|
| Experimental: Oxycodone Formulation D Capsule<br>single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block | Drug: Oxycodone<br>* 1X40 mg PF-00345439 formulation D capsule with water and under fed condition<br>|
| Experimental: Oxycodone Oral Solution<br>40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block | Drug: Oxycodone<br>* 40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 
| Plasma Decay Half-Life of oxycodone, as data permit. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 
| Concentration at time 24 hours (C24) of oxycodone, as data permit. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 
| Adverse events, vital signs and laboratory parameters. |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, relative bioavailability, oxycodone