Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

Pain Therapeutics34 enrolled

Overview

To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

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).