Single Dose Pharmacokinetics of Egalet® Oxycodone
Information source: Egalet a/s
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Oxycodone hydrochloride (Drug); Oxycodone hydrochloride (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Egalet a/s Official(s) and/or principal investigator(s): Christine Andersen, M.Sc., Study Director, Affiliation: Egalet a/s
Summary
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®
oxycodone formulations and compare to a marketed oxycodone product.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.
Secondary outcome: To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Quebec, Canada
Additional Information
Starting date: September 2008
Last updated: September 30, 2013
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