MedTrace Logo

Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

NCT01456507 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-28

No results posted yet for this study

Summary

The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Conditions

  • Healthy

Interventions

DRUG

ALO-02 (Oxycodone Naltrexone)

single dose of ALO-02 capsule under fasting condition

DRUG

ALO-02 (Oxycodone Naltrexone)

single dose of ALO-02 capsule under fed condition

DRUG

ALO-02 (Oxycodone Naltrexone)

ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456507 on ClinicalTrials.gov