Single Dose Pharmacokinetics of Egalet® Oxycodone

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Québec, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone hydrochloride

Drug

Extended release tablet

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Dec 4, 2008
Registry last updated: Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed