Single Dose Pharmacokinetics of Egalet® Oxycodone - Full Text View

Sponsored by:	Egalet a/s
Information provided by:	Egalet a/s
ClinicalTrials.gov Identifier:	NCT00801788

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 I

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

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 ]

Estimated 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
Egalet® oxycodone Treatment A: Experimental Single Dose Administration	Drug: Oxycodone hydrochloride Extended release tablet
Egalet® oxycodone Treatment B: Experimental Single Dose Administration	Drug: Oxycodone hydrochloride Extended release tablet
Egalet® oxycodone Treatment C: Experimental 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

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 ( Helle Toftegaard Clausen, M.Sc., CRA/Medical writer )
Study ID Numbers:	OC-EG-001
Study First Received:	December 2, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00801788 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Oxycodone
Central Nervous System Depressants
Narcotics
Pain

Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Oxycodone
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009