Single Dose Pharmacokinetics of Egalet® Oxycodone

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Egalet Ltd
• Treatments: Oxycodone

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