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NCT01456507 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01456507 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 24 participants.

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The verdict

NCT01456507, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

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.

Interventions

  • DRUG ALO-02 (Oxycodone Naltrexone)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2011-10
Est. Completion 2012-01
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01456507

The ClinicalTrials.gov registry entry for NCT01456507 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ALO-02 (Oxycodone Naltrexone) is the first listed.

NCT01456507 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01456507 about?

NCT01456507 is a clinical study titled "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". 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.

What is the current status of trial NCT01456507?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-10. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01456507?

The interventions under investigation include: ALO-02 (Oxycodone Naltrexone) (DRUG).

Who is sponsoring clinical trial NCT01456507?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.