HealthyNCT01677065
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
An observational study of Healthy, run by Pfizer at 1 site in United States.
Trial summary
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Immediate-release reference drug
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers
Who may be able to join
- healthy volunteers, greater than 50 kg, able and willing to sign informed consent
Who cannot join
- Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
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
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Read the detailed description
Serial sampling of venous blood
- Conditions
- Healthy
- Being tested
- Oxycodone controlled-release test formulation, Immediate-release reference drug
- Keywords
- Bioavailability, Oxycodone, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone controlled-release test formulationDrug
Also called ALO-02
single dose administration of test formulation under fasted conditions
Immediate-release reference drugDrug
Also called Roxicodone
single dose administration of reference drug under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Controlled release oxycodone test formulation 40 mg Receives: Drug: Oxycodone controlled-release test formulation | |
| Treatment B | Immediate release oxycodone reference drug 20 mg Receives: Drug: Immediate-release reference drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic endpoints - area under the concentration curve (AUC)
Measured: 0-48 hr
Secondary outcomes (1)
Peak concentration (Cmax) and time to peak concentration (Tmax)
Measured: 0-48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677065
- Sponsor's protocol ID
- B4531007
- Other IDs
- ALO-02 Bioavailability Study
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2012
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01677065
- Acronym / sponsor ID
- B4531007
- Conditions
- Healthy
- Keywords
- Bioavailability, Oxycodone, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | – | Drug: Oxycodone controlled-release test formulationControlled release oxycodone test formulation 40 mg |
| Treatment B | – | Drug: Immediate-release reference drugImmediate release oxycodone reference drug 20 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (1 listed)
- healthy volunteers, greater than 50 kg, able and willing to sign informed consent
Key exclusion criteria (1 listed)
- Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone controlled-release test formulationAlso: ALO-02single dose administration of test formulation under fasted conditions | Drug | Treatment A |
| Immediate-release reference drugAlso: Roxicodonesingle dose administration of reference drug under fasted conditions | Drug | Treatment B |
Primary outcome
pharmacokinetic endpoints - area under the concentration curve (AUC)
Time frame: 0-48 hr
1 secondary outcome
Peak concentration (Cmax) and time to peak concentration (Tmax)
Time frame: 0-48 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetic endpoints - area under the concentration curve (AUC) (time frame: 0-48 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.