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
28 participants
INTERVENTIONAL
2008-11-30
2009-04-30
Brief Summary
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Detailed Description
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Pharmacokinetic parameters and bioequivalence testing.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Egalet® hydrocodone treatment A
Single Dose administration
hydrocodone
Extended Release tablet
Egalet® hydrocodone Treatment B
Single Dose Administration
hydrocodone
Extended Release tablet
Egalet® hydrocodone Treatment C
Single Dose Administration
hydrocodone
Extended Release tablet
Egalet® hydrocodone Treatment D
Single Dose Administration
hydrocodone
Extended Release tablet
Active Comparator
Single Dose Administration
hydrocodone & acetaminophen combination
Immediate Release tablet, hydrocodone and acetaminophen combination product
Interventions
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hydrocodone
Extended Release tablet
hydrocodone & acetaminophen combination
Immediate Release tablet, hydrocodone and acetaminophen combination product
Eligibility Criteria
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Inclusion Criteria
* ≥18 and ≤55 years of age
* BMI ≥19 and ≤30.0
Exclusion Criteria
* History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
* Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
* 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.Pharm
Role: STUDY_DIRECTOR
Egalet A/S
Locations
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Montreal, Quebec, Canada
Countries
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Other Identifiers
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HC-EG-001
Identifier Type: -
Identifier Source: org_study_id
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