Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
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
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
Adverse events, vital signs and laboratory parameters.	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

Collaborators and Investigators

• Sponsor: Pain Therapeutics

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; relative bioavailability; oxycodone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: B4501010