Single Dose Pharmacokinetics of Egalet® Oxycodone

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801788

Enrollment

Registered

2008-12-04

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

Interventions

DRUGOxycodone hydrochloride

Extended release tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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.	Single-dose evaluation

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026