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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01677065
First received: August 29, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • pharmacokinetic endpoints - area under the concentration curve (AUC) [ Time Frame: 0-48 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak concentration (Cmax) and time to peak concentration (Tmax) [ Time Frame: 0-48 hr ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01677065     History of Changes
Other Study ID Numbers: B4531007, ALO-02 Bioavailability Study
Study First Received: August 29, 2012
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioavailability
Oxycodone
Healthy Volunteers

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

ClinicalTrials.gov processed this record on May 16, 2013