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Single Dose Pharmacokinetics of Egalet® Oxycodone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd
ClinicalTrials.gov Identifier:
NCT00801788
First received: December 2, 2008
Last updated: August 26, 2016
Last verified: August 2016
  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
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Egalet Ltd:

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 ]

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 ]

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   (Adult)
Sexes Eligible for Study:   All
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 Ltd
Investigators
Study Director: Christine Andersen, M.Sc. Egalet A/S
  More Information

Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00801788     History of Changes
Other Study ID Numbers: OC-EG-001
Study First Received: December 2, 2008
Last Updated: August 26, 2016

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

ClinicalTrials.gov processed this record on March 22, 2017