Single Dose Pharmacokinetics of Egalet® Oxycodone

August 26, 2016 updated by: Egalet Ltd
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Main inclusion criteria:

  • ≥18 years and ≤55 years
  • Non-smoker
  • BMI ≥18.0 and ≤30.0

Main exclusion criteria:

  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening
  • History of allergic reactions to opioids or other related drugs
  • History of significant alcohol abuse or drug abuse
  • Use of any drugs known to inhibit hepatic drug metabolism
  • Pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Egalet® oxycodone Treatment A
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
EXPERIMENTAL: Egalet® oxycodone Treatment B
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
EXPERIMENTAL: Egalet® oxycodone Treatment C
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
ACTIVE_COMPARATOR: Active comparator
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.
Time Frame: Single-dose evaluation
Single-dose evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.
Time Frame: Single-dose evaluation
Single-dose evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egalet Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC-EG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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