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

- Provide written informed consent;

- Body weight ranging from 50 to 100 kilograms (kg) [110 to 220 pounds] and body mass index (BMI) of 18 to 30 (kg/m2);

- Males and females aged 18 to 50 years;

- Willing to eat the food supplied during the study;

- Willing to refrain from strenuous exercise through the end-of-study visit. Subjects did not begin a new exercise program nor participate in any unusually strenuous physical exertion;

- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and safety 12-lead ECG;

- Females of childbearing potential must use an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must be postmenopausal for ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).

- 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:

- 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;

- The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.