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
Phase 1
Completed
16 enrolled
USWM, LLC (dba US WorldMeds)
National Institute on Drug Abuse (NIDA) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lofexidine | Small molecule | 0.36 mg | Oral |
Indications
No indication recorded.