drugset / Trial / NCT04188730

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

NCT04188730

RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2021-02-16
Primary completion
2021-03-26
Completion
2021-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Lofexidine Small molecule 0.36 mg Oral

Indications

No indication recorded.