A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01099709
First received: April 6, 2010
Last updated: April 13, 2010
Last verified: April 2010
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Purpose
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Reformulated OXY (oxycodone HCl) Drug: Original OxyContin® (OXY) (oxycodone HCl) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets |
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ] [ Designated as safety issue: No ]Bioeqivalence based on Cmax.
- AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over a 72-hour time period ] [ Designated as safety issue: No ]Bioequivalence 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 ] [ Designated as safety issue: No ]Bioequivalence based on AUC0-t
| Enrollment: | 85 |
| Study Start Date: | January 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Reformulated OXY 10 mg
Reformulated OXY 10 mg x 1 dose
|
Drug: Reformulated OXY (oxycodone HCl)
Reformulated OXY 10-mg tablet x 1 dose taken with food.
|
|
Active Comparator: Original OxyContin® (OXY) 10 mg
Original OxyContin® (OXY) 10 mg x 1 dose
|
Drug: Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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:
- 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 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Monitor, Purdue Pharma L.P. |
| ClinicalTrials.gov Identifier: | NCT01099709 History of Changes |
| Other Study ID Numbers: | OTR1002 |
| Study First Received: | April 6, 2010 |
| Results First Received: | April 13, 2010 |
| Last Updated: | April 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
healthy subjects opioid |
Additional relevant MeSH terms:
|
Oxycodone Narcotics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Analgesics |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 21, 2013