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Single Dose Pharmacokinetics of Egalet® Oxycodone

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ClinicalTrials.gov Identifier: NCT00801788
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone hydrochloride Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : September 2008
Primary Completion Date : October 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 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