Status:
COMPLETED
Single Dose Pharmacokinetics of Egalet® Hydrocodone
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® hydrocodone formulations and compare to a marketed hydrocodone drug.
Detailed Description
Outcomes: Pharmacokinetic parameters and bioequivalence testing.
Eligibility Criteria
Inclusion
- Non-smokers
- ≥18 and ≤55 years of age
- BMI ≥19 and ≤30.0
Exclusion
- Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00802087
Start Date
November 1 2008
End Date
April 1 2009
Last Update
August 29 2016
Active Locations (1)
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1
Montreal, Quebec, Canada