Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Purdue Pharma LP
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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).
You may not be if
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;
Clareo Health | The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects
