About this trial
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
Disqualifiers
Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
Positive urine drug or alcohol results at Screening or check in (Day -1).
Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
Trial design
Crossover
Treatments tested in this trial
NAL ER
DrugOral tablets
Treatment groups
Trial outcomes
Primary outcomes
Relative Bioavailability of NAL ER
Secondary outcomes
Maximum Plasma Concentration (Cmax) of NAL ER
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER
Sponsors and contacts
Click on the lead sponsor to view all of their trials.