Single Dose Pharmacokinetics of Egalet® Oxycodone
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pain
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 29, 2016
August 1, 2016
1 month
December 2, 2008
August 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.
Single-dose evaluation
Study Arms (4)
Egalet® oxycodone Treatment A
EXPERIMENTALSingle Dose Administration
Egalet® oxycodone Treatment B
EXPERIMENTALSingle Dose Administration
Egalet® oxycodone Treatment C
EXPERIMENTALSingle Dose Administration
Active comparator
ACTIVE COMPARATORSingle Dose Administration
Interventions
Extended release tablet
Eligibility Criteria
You may qualify if:
- ≥18 years and ≤55 years
- Non-smoker
- BMI ≥18.0 and ≤30.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egalet Ltdlead
Study Sites (1)
Unknown Facility
Québec, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Andersen, M.Sc.
Egalet A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2008
Study Completion
February 1, 2009
Last Updated
August 29, 2016
Record last verified: 2016-08