At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Relative Bioavailability of a Test Formulation of Lofexidine Granules for Reconstitution and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Lofexidine (granules for reconstitution) and LUCEMYRA (lofexidine) tablets for Normal Healthy Volunteers. Completed, enrolled 16 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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.