Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

Phase 1CompletedNCT02089295

Pain Therapeutics18 enrolled

Overview

To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OxycodoneDRUG

One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions

OxycodoneDRUG

One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed 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 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).