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CompletedNCT01101165Updated May 11, 2010Results posted

To Determine the Fasting 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 2010-05-11.

Sponsored by Purdue Pharma LP · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
92
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 (40 mg) relative to the original OxyContin® (OXY) formulation (40 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.

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 kg and a BMI ≥18 and ≤34 (kg/m2).
  • Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
  • Females of child-bearing potential must be using an adequate and reliable method of contraception.

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 HBsAg, HBsAb (unless immunized), anti-HCV.
  • Positive Naloxone 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
92 participants (actual)

Study arms

  • Experimental
    Reformulated OXY 40 mg

    Reformulated OXY 40 mg x 1 dose

    Drug: Reformulated OXY (oxycodone HCl)

  • Active comparator
    Original OxyContin® (OXY) 40 mg

    Original OxyContin® (OXY) 40 mg x 1 dose

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

Interventions

  • DrugReformulated OXY (oxycodone HCl)

    Reformulated OXY 40-mg tablet x 1 dose taken without food

  • DrugOriginal OxyContin® (OXY) (oxycodone HCl)

    Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Plasma Concentration

    Bioequivalence based on Cmax

    Time frame: Blood samples collected over 72-hour period

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

    Bioequivalence based on AUC0-inf

    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

    Bioequivalence based on AUC0-t

    Time frame: Blood samples collected over 72-hour period

07

Results

Posted May 6, 2010

Participant flow

05-Feb-2007 (first Informed Consent Form signed) to 06-Apr-2007 (last subject follow-up) at 1 site in the US (Evansville, IN).

Period 1
Participant flow — Period 1
MilestoneReformulated OXY (Test) FirstOriginal OxyContin® (OXY) (Reference) First
Started4745
Completed4540
Not completed25
Withdrew: Adverse event12
Withdrew: Withdrawal by subject02
Withdrew: Positive drug screen01
Withdrew: Lost to follow-up10
Period 2
Participant flow — Period 2
MilestoneReformulated OXY (Test) FirstOriginal OxyContin® (OXY) (Reference) First
Started4540
Completed4139
Not completed41
Withdrew: Withdrawal by subject31
Withdrew: Adverse event10

Outcome measures

PrimaryCmax - Maximum Observed Plasma Concentration

Bioequivalence based on Cmax

Time frame:
Blood samples collected over 72-hour period
Reported as:
Mean · ng/mL
Cmax - Maximum Observed Plasma Concentration
ng/mLReformulated OXY (Test)Original OxyContin® (OXY) (Reference)
Cmax - Maximum Observed Plasma Concentration47.4 ± 12.948.4 ± 10.9
Statistical analysis
  • Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 96.6 · 90% CI 92.80 to 100.56Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.
PrimaryAUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf

Time frame:
Blood samples collected over 72-hour period
Reported as:
Mean · ng*h/mL
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
ng*h/mLReformulated OXY (Test)Original OxyContin® (OXY) (Reference)
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)454 ± 116480 ± 120
Statistical analysis
  • Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 94.8 · 90% CI 92.42 to 97.24Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.
PrimaryAUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

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 OXY (Test)Original OxyContin® (OXY) (Reference)
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration453 ± 116477 ± 119
Statistical analysis
  • Reformulated OXY (Test) vs Original OxyContin® (OXY) (Reference) · ANOVA · Geometric test/ref ratio x 100: 95.5 · 90% CI 92.93 to 98.18Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Reformulated OXY (Test)—1/87 (1.1%)30/87 (34.5%)
Original OxyContin® (OXY) (Reference)—0/90 (0%)32/90 (35.6%)
Most frequent serious events
Most frequent serious events
EventReformulated OXY (Test)Original OxyContin® (OXY) (Reference)
Substance abuse (positive for cotinine and amphetamines)Social circumstances1/870/90
Most frequent other events
Most frequent other events
EventReformulated OXY (Test)Original OxyContin® (OXY) (Reference)
FatigueGeneral disorders11/877/90
HeadacheNervous system disorders8/8711/90
NauseaGastrointestinal disorders8/877/90
VomitingGastrointestinal disorders3/877/90

Baseline characteristics

Age Continuous
Age Continuous(years)Randomized Safety Population
Mean31 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Randomized Safety Population
Female31
Male61
08

Study locations

1 site
  • Covance Clinical Research Unit - Evansville
    Evansville, Indiana 47714, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01101165
Lead sponsor
Purdue Pharma LP
First posted
Apr 9, 2010
Start date
Feb 2007
Primary completion
Apr 2007
Completion
Jul 2007
Results posted
May 6, 2010
Last update
May 11, 2010

Oversight

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

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