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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 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04188730
The ClinicalTrials.gov registry entry for NCT04188730 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USWM, LLC (dba US WorldMeds), which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lofexidine (granules for reconstitution) is the first listed.
NCT04188730 reports 0 study locations.
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.
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