HealthyPhase 1NCT01101191

A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

A Phase 1 study testing Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) in people with Healthy, run by Purdue Pharma LP at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Jan 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females aged 18 to 50, inclusive.
Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
Females of child-bearing potential must be using an adequate and reliable method of contraception.
Willing to eat all the food supplied during the study.

Who cannot join

Females who are pregnant or lactating.
Any history of or current drug or alcohol abuse for 5 years.
History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
Use of an opioid-containing medication in the past 30 days.
History of known sensitivity to oxycodone, naltrexone, or related compounds.
Any history of frequent nausea or emesis regardless of etiology.

Show all 17Show fewer

Any history of seizures or head trauma with current sequelae.
Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
Any significant illness during the 30 days preceding the initial dose in this study.
Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
Positive results for urine drug screen or alcohol screen at Check-in of each period, and hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) (unless immunized), anti-hepatitis C antibody (HCV).
Positive Naloxone hydrochloride (HCl) challenge test.
Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit Honolulu
Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.

Read the detailed description

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Conditions: Healthy
Being tested: Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
Keywords: Healthy subjects, Opioid, Healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reformulated OXY (oxycodone HCl)Drug
Reformulated OXY 80-mg tablet x 1 dose taken without food.
Original OxyContin® (OXY) (oxycodone HCl)Drug
Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.

Study groups in NCT01101191
Study group	Role	What they receive
Reformulated OXY 80 mg	Experimental	Reformulated OXY 80 mg x 1 dose Receives: Drug: Reformulated OXY (oxycodone HCl)
Original OxyContin® (OXY) 80 mg	Active comparator	Original OxyContin® (OXY) 80 mg x 1 dose Receives: Drug: Original OxyContin® (OXY) (oxycodone HCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Plasma Concentration
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Measured: Blood samples collected over a 72-hour period.
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.
Measured: Blood samples collected over 72-hour period
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.
Measured: Blood samples collected over 72-hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Jan 2008

First posted9 Apr 2010 (estimated)
Study startAug 2007
Primary completionOct 2007
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101191
Sponsor's protocol ID: OTR1009
Status last verified: May 2010
First submitted: 8 Apr 2010
Last updated: 25 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets
ClinicalTrials.gov ID: NCT01101191
Acronym / sponsor ID: OTR1009
Conditions: Healthy
Keywords: Healthy subjects, Opioid, Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Oct 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 9 Apr 2010 (estimated)
Results: Posted 11 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.

Detailed description

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reformulated OXY 80 mg	Experimental	Drug: Reformulated OXY (oxycodone HCl)Reformulated OXY 80 mg x 1 dose
Original OxyContin® (OXY) 80 mg	Active comparator	Drug: Original OxyContin® (OXY) (oxycodone HCl)Original OxyContin® (OXY) 80 mg x 1 dose

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males and females aged 18 to 50, inclusive.
Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
Females of child-bearing potential must be using an adequate and reliable method of contraception.
Willing to eat all the food supplied during the study.

Key exclusion criteria (17 listed)

Females who are pregnant or lactating.
Any history of or current drug or alcohol abuse for 5 years.
History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
Use of an opioid-containing medication in the past 30 days.
History of known sensitivity to oxycodone, naltrexone, or related compounds.

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
Reformulated OXY (oxycodone HCl)Reformulated OXY 80-mg tablet x 1 dose taken without food.	Drug	Reformulated OXY 80 mg
Original OxyContin® (OXY) (oxycodone HCl)Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.	Drug	Original OxyContin® (OXY) 80 mg

Primary outcome

Cmax - Maximum Observed Plasma Concentration
Time frame: Blood samples collected over a 72-hour period.
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 72-hour period
AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
Time frame: Blood samples collected over 72-hour period
AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.

Results and safety

Results posted to the registry on 11 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reformulated OXY (Test)	42	40
Original OxyContin® (OXY) (Reference)	42	40

Primary outcome: Cmax - Maximum Observed Plasma Concentration

Time frame: Blood samples collected over a 72-hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Reformulated OXY (Test) n = 78	Original OxyContin® (OXY) (Reference) n = 73
Value	85.1 (21.5)	83.0 (20.1)

Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference): Geometric Test/Ref Ratio x 100: 103 (90% CI 98.67 to 106.66), ANOVA

Population analysed: Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Primary outcome: AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Time frame: Blood samples collected over 72-hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Reformulated OXY (Test) n = 78	Original OxyContin® (OXY) (Reference) n = 71
Value	966 (269)	989 (243)

Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference): Geometric Test/Ref Ratio x 100: 97.0 (90% CI 94.20 to 99.81), ANOVA

Primary outcome: AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Time frame: Blood samples collected over 72-hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Reformulated OXY (Test) n = 78	Original OxyContin® (OXY) (Reference) n = 72
Value	964 (269)	981 (243)

Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference): Geometric Test/Ref Ratio x 100: 97.1 (90% CI 94.41 to 99.94), ANOVA

Population analysed: Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Adverse events

Time frame: Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution or up to 30 days after last dose. All SAEs were followed until resolution or event/sequelae stabilized.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reformulated OXY (Test)	0 of 82 (0%)	47 of 82 (57.3%)	Not reported
Original OxyContin® (OXY) (Reference)	0 of 82 (0%)	69 of 82 (84.1%)	Not reported
Prerandomization	1 of 136 (0.7%)	0 of 136 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) in people with Healthy, run by Purdue Pharma LP 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 5 inclusion and 17 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 25 May 2010. 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?

Yes. Results are posted in the registry (first posted 11 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax - Maximum Observed Plasma Concentration (time frame: Blood samples collected over a 72-hour period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101191.

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 25 May 2010.