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To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

2014-08-27 03:14:40 | BioPortfolio

Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.

Description

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)

Location

Covance Clinical Research Unit - Evansville
Evansville
Indiana
United States
47714

Status

Completed

Source

Purdue Pharma LP

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:40-0400

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The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.

A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

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PubMed Articles [5994 Associated PubMed Articles listed on BioPortfolio]

Prophylactic vaccination protects against the development of oxycodone self-administration.

Abuse of prescription opioids is a growing public health crisis in the United States, with drug overdose deaths increasing dramatically over the past 15 years. Few preclinical studies exist on the rei...

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Oxycodone or dexmedetomidine (DEX) alone are widely used in clinical practice. The aim of this study was to observe the effect of two oxycodone and DEX combinations on postoperative sleep quality.

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation.

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Relapse to nonmedical use of prescription opioids often occurs after exposure to places previously associated with drug use. Here, we describe a rat model of context-induced reinstatement of oxycodone...

Medical and Biotech [MESH] Definitions

Semisynthetic derivative of CODEINE that acts as a narcotic analgesic more potent and addicting than codeine.

A system of therapeutics founded by Samuel Hahnemann (1755-1843), based on the Law of Similars where "like cures like". Diseases are treated by highly diluted substances that cause, in healthy persons, symptoms like those of the disease to be treated. The dilutions are repeated so many times that there is less than one molecule per dose and it is suggested that benefit is from the energetic life force of the original substance.

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

A high-molecular-weight polymeric elastomer derived from the milk juice (LATEX) of HEVEA brasiliensis and other trees and plants. It is a substance that can be stretched at room temperature to at least twice its original length and after releasing the stress, retract rapidly, and recover its original dimensions fully.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

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