Overview

A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution

Status:
Completed

Trial end date:
2021-03-26

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

US WorldMeds LLC

Collaborator:

National Institute on Drug Abuse (NIDA)

Treatments:

Clonidine
Lofexidine