Single Dose Pharmacokinetics of Egalet® Oxycodone

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801788
• Other study ID #: OC-EG-001
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2008
• Last updated: August 26, 2016
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2016
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Oxycodone hydrochloride
Extended release tablet
• Oxycodone hydrochloride
Extended release tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.		Single-dose evaluation	No
Secondary	To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.		Single-dose evaluation	Yes