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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: USWM, LLC (dba US WorldMeds) · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lofexidine (granules for reconstitution)	All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
DRUG	LUCEMYRA (lofexidine) tablets	All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-03-26
• Completion: 2021-03-26
• First posted: 2019-12-06
• Last updated: 2022-06-15
• Results posted: 2022-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study