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NCT04188730 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04188730: Completed Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT04188730 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04188730, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
The peak exposure plasma concentrations (Cmax) of lofexidine were observed and measured.
Interventions
- DRUG Lofexidine (granules for reconstitution)
- DRUG LUCEMYRA (lofexidine) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2021-03-26 |
| Phase | Phase 1 |
What the finished NCT04188730 record still lists
NCT04188730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Lofexidine (granules for reconstitution) is the first listed.
NCT04188730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04188730 about?
NCT04188730 is a clinical study titled "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". 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 e...
What is the current status of trial NCT04188730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-02-16. Estimated completion is 2021-03-26.
What interventions are being tested in trial NCT04188730?
The interventions under investigation include: Lofexidine (granules for reconstitution) (DRUG), LUCEMYRA (lofexidine) tablets (DRUG).
Who is sponsoring clinical trial NCT04188730?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04188730's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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