Status:
COMPLETED
Single Dose Pharmacokinetics of Egalet® Oxycodone
Lead Sponsor:
Egalet Ltd
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00801788
Start Date
September 1 2008
End Date
February 1 2009
Last Update
August 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Québec, Quebec, Canada