To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
- healthy volunteers, greater than 50 kg, able and willing to sign informed consent
- Evidence of significant illness, condition affecting drug absorption, history of sleep
apnea, and allergy to opioid drugs
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | 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 | |||
| 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 | |||
| Brief Summary | To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug. | |||
| Detailed Description | Serial sampling of venous blood | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Crossover Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Healthy adult volunteers | |||
| Condition | Healthy | |||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 14 | |||
| Original Estimated Enrollment | Same as current | |||
| Actual Study Completion Date | October 2012 | |||
| Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01677065 | |||
| Other Study ID Numbers | B4531007 ALO-02 Bioavailability Study | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | September 2018 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
