Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

Pain Therapeutics18 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pain

Interventions

OxycodoneDRUG

1X40 mg PF-00345439 formulation A capsule with water and under fed condition

OxycodoneDRUG

1X40 mg PF-00345439 formulation B capsule with water and under fed condition

OxycodoneDRUG

1X40 mg PF-00345439 formulation C capsule with water and under fed condition

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

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.