The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects

Exclusion Criteria

• •Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating;
• •Current or recent (within 5 years) history of drug or alcohol abuse;
• •History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion;
• •Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study;
• •Known allergy to hydrocodone, opioids, psychotropic or hypnotic drugs, moxifloxacin, or any member of the quinolone class drugs;
• •Any history of frequent nausea or emesis regardless of etiology;
• •Any history of seizures or head trauma with sequelae;
• •Participation in a clinical drug study during the 30 days preceding the initial dose of study drug in this study;
• •Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose of study drug;
• •Any significant illness during the 30 days preceding the initial dose of study drug in this study;
• •Any personal or family history of prolonged QT interval or disorders of cardiac rhythm;
• •Abnormal cardiac conditions including hypertension;
• •Abnormal cardiac condition denoted by any of the following:
• •* QT data corrected for heart rate using the Fridericia formula (QTcF) interval \>450 milliseconds (msec)
• •* PR interval \>240 msec or QRS \>110 msec
• •* Evidence of second- or third-degree atrioventricular block
• •* Pathological Q-waves (defined as Q-wave \>40 msec or depth \>0.5 millivolts \[mV\])
• •* Evidence of ventricular pre-excitation, complete left bundle branch block (LBBB), right bundle branch block (RBBB), or incomplete RBBB
• •* With a resting heart rate (HR) outside the range of 40 to 90 beats per minute (bpm);
• •Abnormalities on physical examination, vital signs, safety 12-lead ECG, or clinical laboratory values, unless those abnormalities are judged clinically insignificant by the investigator;
• •Oxygen saturation \<94% as measured by pulse oximetry (SpO2);
• •Refusal to abstain completely from caffeine or xanthine during confinement;
• •Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration through the end-of-study visit;
• •Blood or blood products donated within 30 days prior to initial study drug administration or any time through the end-of-study visit, except as required by the study protocol;
• •History of smoking or use of nicotine products within 45 days of initial study drug administration or a positive urine cotinine test;
• •Positive results of urine drug screen or alcohol screen;
• •Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV);
• •Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities;