Phase 1
Completed N=55
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Healthy
Source: ClinicalTrials.gov NCT01101308 ↗
Enrolled (actual)
55
Serious AEs
0.4%
Results posted
May 2010
Primary outcomePrimary: Cmax - Maximum Observed Plasma Concentration — 9.81; 9.58 ng/mL
Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax - Maximum Observed Plasma Concentration |
9.81; 9.58 | — |
| PRIMARY AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) |
112; 111 | — |
| PRIMARY AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration |
111; 110 | — |
Eligibility Criteria
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.
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 hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) (unless immunized), anti-hepatitis C antibody (HCV).
- Positive Naloxone hydrochloride (HCl) challenge test.
- Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Data sourced from ClinicalTrials.gov (NCT01101308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.