Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2008-09-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Egalet® oxycodone Treatment A
Single Dose Administration
Oxycodone hydrochloride
Extended release tablet
Egalet® oxycodone Treatment B
Single Dose Administration
Oxycodone hydrochloride
Extended release tablet
Egalet® oxycodone Treatment C
Single Dose Administration
Oxycodone hydrochloride
Extended release tablet
Active comparator
Single Dose Administration
Oxycodone hydrochloride
Extended release tablet
Interventions
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Oxycodone hydrochloride
Extended release tablet
Oxycodone hydrochloride
Extended release tablet
Eligibility Criteria
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Inclusion Criteria
* Non-smoker
* BMI ≥18.0 and ≤30.0
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Egalet Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Andersen, M.Sc.
Role: STUDY_DIRECTOR
Egalet A/S
Locations
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Québec, Quebec, Canada
Countries
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Other Identifiers
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OC-EG-001
Identifier Type: -
Identifier Source: org_study_id
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