CClinicalTrials.gg
Sign In
CompletedNCT01101178Updated Oct 10, 2011Results posted

To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

A Phase 1 interventional study of Reformulated OXY (oxycodone HCl) and Original OxyContin® (OXY) (oxycodone HCl) in Healthy, sponsored by Purdue Pharma LP. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-10.

Sponsored by Purdue Pharma LP · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 fed 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy subjects
  • Opioid
  • Healthy volunteers
03

In context

Lead sponsor

Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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), hepatitis C antibody (anti-HCV).
  • Positive Naloxone hydrochloride (HCl) challenge test.
  • Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Reformulated OXY 80 mg

    Reformulated OXY 80 mg x 1 dose

    Drug: Reformulated OXY (oxycodone HCl)

  • Active comparator
    Original OxyContin® (OXY) 80 mg

    Original OxyContin® (OXY) 80 mg x 1 dose

    Drug: Original OxyContin® (OXY) (oxycodone HCl)

Interventions

  • DrugReformulated OXY (oxycodone HCl)

    Reformulated OXY 80-mg tablet x 1 dose taken with food.

  • DrugOriginal OxyContin® (OXY) (oxycodone HCl)

    Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Plasma Concentration

    Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.

    Time frame: Blood samples collected over 72-hour period

  2. AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

    AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.

    Time frame: Blood samples collected over 72-hour period

  3. 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 Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t

    Time frame: Blood samples collected over 72-hour period

07

Results

Posted May 10, 2010

Participant flow

23-Aug-2007 to 26-Nov-2007 at 1 site in the US (Madison, WI).

Period 1
Participant flow — Period 1
MilestoneReformulated OXY (Test) FirstOriginal OxyContin® (OXY) (Reference) First
Started4039
Completed3635
Not completed44
Withdrew: Withdrawal by subject12
Withdrew: Positive drug screen11
Withdrew: Adverse event21
Period 2
Participant flow — Period 2
MilestoneReformulated OXY (Test) FirstOriginal OxyContin® (OXY) (Reference) First
Started3635
Completed3634
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryCmax - Maximum Observed Plasma Concentration

Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.

Time frame:
Blood samples collected over 72-hour period
Reported as:
Mean · ng/mL
Cmax - Maximum Observed Plasma Concentration
ng/mLReformulated Oxycodone (OXY) (Test)Original OxyContin® (OXY) (Reference)
Cmax - Maximum Observed Plasma Concentration109 ± 27.997.6 ± 19.9
Statistical analysis
  • Reformulated Oxycodone (OXY) (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 110 · 90% CI 105.21 to 114.47Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.
PrimaryAUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.

Time frame:
Blood samples collected over 72-hour period
Reported as:
Mean · ng*h/mL
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
ng*h/mLReformulated Oxycodone (OXY) (Test)Original OxyContin® (OXY) (Reference)
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)1033 ± 2691070 ± 275
Statistical analysis
  • Reformulated Oxycodone (OXY) (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 94.7 · 90% CI 92.71 to 96.64Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.
PrimaryAUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t

Time frame:
Blood samples collected over 72-hour period
Reported as:
Mean · ng*h/mL
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
ng*h/mLReformulated Oxycodone (OXY) (Test)Original OxyContin® (OXY) (Reference)
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration1030 ± 2671064 ± 274
Statistical analysis
  • Reformulated Oxycodone (OXY) (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 94.9 · 90% CI 92.90 to 97.02Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

Adverse events

Collected over Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Reformulated OXY (Test)—1/75 (1.3%)53/75 (70.7%)
Original OxyContin® (OXY) (Reference)—1/75 (1.3%)43/75 (57.3%)
Screening—2/169 (1.2%)0/169 (0%)
Most frequent serious events
Most frequent serious events
EventReformulated OXY (Test)Original OxyContin® (OXY) (Reference)Screening
Positive drug screen (Cannabinoids)Social circumstances0/751/752/169
Positive drug screen (Cocaine)Social circumstances1/750/750/169
Most frequent other events
Most frequent other events
EventReformulated OXY (Test)Original OxyContin® (OXY) (Reference)Screening
HeadacheNervous system disorders16/7514/750/169
NauseaGastrointestinal disorders13/758/750/169
DizzinessNervous system disorders9/755/750/169
SomnolenceNervous system disorders8/758/750/169
VomitingGastrointestinal disorders3/755/750/169
FatigueGeneral disorders4/753/750/169

Baseline characteristics

Age Continuous
Age Continuous(years)Randomized Safety Population
Mean29 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Randomized Safety Population
Female32
Male47
08

Study locations

1 site
  • Covance Clinical Research Unit Madison
    Madison, Wisconsin 53704, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01101178
Lead sponsor
Purdue Pharma LP
Responsible party
Sponsor
First posted
Apr 9, 2010
Start date
Aug 2007
Primary completion
Nov 2007
Completion
Nov 2007
Results posted
May 10, 2010
Last update
Oct 10, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Purdue Pharma LP

Start the discussion