HealthyPhase 1NCT00853892
Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
A Phase 1 study testing OxyContin® 40 mg tablet in people with Healthy, run by Mallinckrodt at 1 site in United States.
Trial summary
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OxyContin® 40 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2005
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-lactating females, 18 years of age or older.
- Female subjects must be postmenopausal for at least one year, surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation. All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation.
- Weight must be within 15% of the ideal weight for height and frame, as adopted by the Metropolitan Life Insurance Co., 1999.
- Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
- The normal status of subjects will be confirmed by the following procedures:
- Laboratory tests (serum chemistry, hematology, urinalysis). A subject with laboratory values that are not within the clinical laboratory's reference range does not qualify, unless specifically accepted (with comment) by the investigator.
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- Human immunodeficiency virus (HIV), drugs of abuse, alcohol, and hepatitis B and C testing will be performed at screening. Results of these tests must be negative or non-reactive for subjects to qualify for the study. At each check-in to the study site, a urine drug screen will be performed that must be negative for continued participation.
- Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects at screening. Appropriately trained and experienced medical personnel must interpret this ECG. A subject with an ECG that is not within normal range does not qualify, unless specifically accepted (with comment) by the investigator.
- Subjects must be able to provide written consent and agree to abide by the study requirements.
Who cannot join
- History of chronic alcohol, drug, or narcotic abuse.
- Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
- History or presence of major organ dysfunction.
- History of malignancy, stroke, or diabetes; cardiac, renal, liver, pulmonary, or severe gastrointestinal disease; or other serious illness.
- History of anxiety, tension, severe agitation, psychosis, or mental depression.
- Family history or diagnosis of epilepsy or other seizure disorder.
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- History of acute abdominal or pelvic conditions.
- History of conditions which might contraindicate or require caution be used in the administration of oxycodone, including renal impairment, hepatobiliary or pancreatic disease, GI obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or allergy to oxycodone, or history of hypersensitivity to any opiate agonist
- Administration of any other investigational drug during the 30 days prior to enrollment into the study.
- Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry.
- Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
- Subjects presenting with acute illness.
- Subjects who have taken prescription drugs within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to dosing except for standard daily dose multivitamins.
- Subjects who have a positive Narcan® challenge.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications
Springfield, Missouri, 65801
About this study
Official title: An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fasting Conditions
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Controlled-Release Oxycodone Hydrochloride 40 mg tablet, OxyContin® 40 mg tablet
- Keywords
- Healthy Subjects, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled-Release Oxycodone Hydrochloride 40 mg tabletDrug
Controlled-Release Oxycodone Hydrochloride 40 mg, single dose fasting
OxyContin® 40 mg tabletDrug
OxyContin® 40 mg tablet, single dose fasting
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Controlled-Release Oxycodone Hydrochloride 40 mg tablet Receives: Drug: Controlled-Release Oxycodone Hydrochloride 40 mg tablet |
| B | Active comparator | OxyContin® 40 mg tablet Receives: Drug: OxyContin® 40 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUCf, AUCinf and Cmax
Measured: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 36 hours. Washout period between doses was 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2005
- Study completionApr 2005
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.
- 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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853892
- Sponsor's protocol ID
- 0595-05-812
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2009
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00853892
- Acronym / sponsor ID
- 0595-05-812
- Conditions
- Healthy
- Keywords
- Healthy Subjects, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 2 Mar 2009 (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.
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Controlled-Release Oxycodone Hydrochloride 40 mg tabletControlled-Release Oxycodone Hydrochloride 40 mg tablet |
| B | Active comparator | Drug: OxyContin® 40 mg tabletOxyContin® 40 mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or non-pregnant, non-lactating females, 18 years of age or older.
- Female subjects must be postmenopausal for at least one year, surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation. All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation.
- Weight must be within 15% of the ideal weight for height and frame, as adopted by the Metropolitan Life Insurance Co., 1999.
- Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
- The normal status of subjects will be confirmed by the following procedures:
Key exclusion criteria (14 listed)
- History of chronic alcohol, drug, or narcotic abuse.
- Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
- History or presence of major organ dysfunction.
- History of malignancy, stroke, or diabetes; cardiac, renal, liver, pulmonary, or severe gastrointestinal disease; or other serious illness.
- History of anxiety, tension, severe agitation, psychosis, or mental depression.
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 |
|---|---|---|
| Controlled-Release Oxycodone Hydrochloride 40 mg tabletControlled-Release Oxycodone Hydrochloride 40 mg, single dose fasting | Drug | A |
| OxyContin® 40 mg tabletOxyContin® 40 mg tablet, single dose fasting | Drug | B |
Primary outcome
Bioequivalence based on AUCf, AUCinf and Cmax
Time frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 36 hours. Washout period between doses was 7 days.
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 9 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OxyContin® 40 mg tablet in people with Healthy, run by Mallinckrodt 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 9 inclusion and 14 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 9 Sep 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bioequivalence based on AUCf, AUCinf and Cmax (time frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 36 hours. Washout period between doses was 7 days.). 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 9 Sep 2016.