Single Dose Pharmacokinetics of Egalet® Oxycodone

NCT ID: NCT00801788

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Egalet® oxycodone Treatment A

Single Dose Administration

Group Type EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type DRUG

Extended release tablet

Egalet® oxycodone Treatment B

Single Dose Administration

Group Type EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type DRUG

Extended release tablet

Egalet® oxycodone Treatment C

Single Dose Administration

Group Type EXPERIMENTAL

Oxycodone hydrochloride

Intervention Type DRUG

Extended release tablet

Active comparator

Single Dose Administration

Group Type ACTIVE_COMPARATOR

Oxycodone hydrochloride

Intervention Type DRUG

Extended release tablet

Interventions

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Oxycodone hydrochloride

Extended release tablet

Intervention Type DRUG

Oxycodone hydrochloride

Extended release tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Egalet Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Andersen, M.Sc.

Role: STUDY_DIRECTOR

Egalet A/S

Locations

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Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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OC-EG-001

Identifier Type: -

Identifier Source: org_study_id

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