Single Dose Pharmacokinetics of Egalet® Oxycodone

Egalet

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Oxycodone hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00801788

OC-EG-001

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

16 participants in 4 patient groups

Egalet® oxycodone Treatment A

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: Oxycodone hydrochloride

Drug: Oxycodone hydrochloride

Egalet® oxycodone Treatment B

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: Oxycodone hydrochloride

Drug: Oxycodone hydrochloride

Egalet® oxycodone Treatment C

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: Oxycodone hydrochloride

Drug: Oxycodone hydrochloride

Active comparator

Active Comparator group

Description:

Single Dose Administration

Treatment:

Drug: Oxycodone hydrochloride

Drug: Oxycodone hydrochloride