Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Phase 1CompletedNCT01924676

Pain Therapeutics18 enrolled

Overview

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers. Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OxycodoneDRUG

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

OxycodoneDRUG

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

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed 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 (inclusive). Exclusion Criteria: * Evidence or history of clinically significant disease * Positive urine drug test

Locations (1)

Pfizer Investigational Site

Baltimore, Maryland, 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).