Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions

Phase 1CompletedNCT02059915

Pain Therapeutics134 enrolled

Overview

To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

134

Conditions

Healthy

Interventions

OxycodoneDRUG

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

OxycodoneDRUG

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

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation X, 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 (1)

Pfizer Investigational Site

Saint Paul, Minnesota, 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).