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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oral tablets
Clinical Pharmacology of Miami, LLC.
Miami, Florida, United States
Relative Bioavailability of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Maximum Plasma Concentration (Cmax) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Rate Constant (λz) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Half-Life (t1/2) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 18
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