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Single Dose Pharmacokinetics of Egalet® Oxycodone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Egalet a/s
ClinicalTrials.gov Identifier:
NCT00801788
First received: December 2, 2008
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Pain
Drug: Oxycodone hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Egalet a/s:

Primary Outcome Measures:
  • To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24. [ Time Frame: Single-dose evaluation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring. [ Time Frame: Single-dose evaluation ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Egalet® oxycodone Treatment A
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
Experimental: Egalet® oxycodone Treatment B
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
Experimental: Egalet® oxycodone Treatment C
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet
Active Comparator: Active comparator
Single Dose Administration
Drug: Oxycodone hydrochloride
Extended release tablet

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801788

Locations
Canada
Quebec, Canada
Sponsors and Collaborators
Egalet a/s
Investigators
Study Director: Christine Andersen, M.Sc. Egalet a/s
  More Information

No publications provided

Responsible Party: Egalet a/s
ClinicalTrials.gov Identifier: NCT00801788     History of Changes
Other Study ID Numbers: OC-EG-001
Study First Received: December 2, 2008
Last Updated: September 30, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014