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

Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Reformulated OXY (oxycodone HCl) (Drug); Original OxyContin® (OXY) (oxycodone HCl) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Purdue Pharma LP

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Plasma Concentration

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

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

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Covance Clinical Research Unit, Honolulu, Hawaii 96813, United States
Additional Information

Starting date: January 2007
Last updated: April 13, 2010

Page last updated: August 23, 2015

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