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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

Page last updated: August 23, 2015

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