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A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677065
First Posted: August 31, 2012
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Condition Intervention Phase
Healthy Drug: Oxycodone controlled-release test formulation Drug: Immediate-release reference drug Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • pharmacokinetic endpoints - area under the concentration curve (AUC) [ Time Frame: 0-48 hr ]

Secondary Outcome Measures:
  • Peak concentration (Cmax) and time to peak concentration (Tmax) [ Time Frame: 0-48 hr ]

Enrollment: 14
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment A
Controlled release oxycodone test formulation 40 mg
Drug: Oxycodone controlled-release test formulation
single dose administration of test formulation under fasted conditions
Other Name: ALO-02
Treatment B
Immediate release oxycodone reference drug 20 mg
Drug: Immediate-release reference drug
single dose administration of reference drug under fasted conditions
Other Name: Roxicodone

Detailed Description:
Serial sampling of venous blood
  Eligibility

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
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers
Criteria

Inclusion Criteria:

  • healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion Criteria:

  • Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs
  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): NCT01677065


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01677065     History of Changes
Other Study ID Numbers: B4531007
ALO-02 Bioavailability Study
First Submitted: August 29, 2012
First Posted: August 31, 2012
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Pfizer:
Bioavailability
Oxycodone
Healthy Volunteers

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