Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01100320
Eligibility 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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01100320
Study Brief:
Protocol Section:
NCT01100320