The purpose of this open-label, single-dose, randomized, three-treatment, three-period, four-sequence, crossover study is to evaluate the relative bioavailability of a test formulation of lofexidine granules for reconstitution (oral) and LUCEMYRA tablets under fasted conditions and to evaluate the effect of food on the relative bioavailability of lofexidine granules for reconstitution (oral) when administered under fed compared to fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States
Mean Maximum Plasma Concentration (Cmax)
The peak exposure plasma concentrations (Cmax) of lofexidine were observed and measured.
Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.
Time to Maximum Plasma Concentration (Tmax)
Time to peak plasma concentration (h) collection time at which Cmax is first observed.
Time frame: Day 1 through Day 3 for Periods I, II, III.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-t)
Areas under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUC0-t)
Time frame: Day 1 through Day 3 for Periods I, II, III.
Area Under the Plasma Concentration-time Curve From Time Zero to Time Infinity (AUC0-∞)
Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.
First-order Terminal Rate Constant (λz)
Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.
First-order Terminal Half-life (T½)
Time frame: Mean from Day 1 through Day 3 for Periods I, II, III.
Occurrence of Adverse Events (AEs)
Number of Subjects dosed for each Treatment groups: Treatment A = 15 subjects dosed; Treatment B = 16 subjects dosed; Treatment C = 15 subjects dosed
Time frame: Total from occurrences assessed daily after each dosing for Periods 1-3, as well as end of study (22 days)
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