- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677065
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
September 26, 2018 updated by: Pfizer
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
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Serial sampling of venous blood
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adult volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment A
Controlled release oxycodone test formulation 40 mg
|
single dose administration of test formulation under fasted conditions
Other Names:
|
Treatment B
Immediate release oxycodone reference drug 20 mg
|
single dose administration of reference drug under fasted conditions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pharmacokinetic endpoints - area under the concentration curve (AUC)
Time Frame: 0-48 hr
|
0-48 hr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak concentration (Cmax) and time to peak concentration (Tmax)
Time Frame: 0-48 hr
|
0-48 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
August 29, 2012
First Submitted That Met QC Criteria
August 30, 2012
First Posted (Estimate)
August 31, 2012
Study Record Updates
Last Update Posted (Actual)
September 28, 2018
Last Update Submitted That Met QC Criteria
September 26, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B4531007
- ALO-02 Bioavailability Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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