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NCT01437306 · ClinicalTrials.gov registry record · Phase 1
Lofexidine Food Effect Study in Healthy Volunteers
A Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01437306: Completed Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT01437306 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437306, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured by US WorldMeds, LLC.
Primary Outcome
Samples will be analyzed for lofexidine concentration and calculations will be performed for the following: Cmax and Tmax will be taken directly from the data. The elimination rate constant, will be calculated as the negative of the slope of the terminal log-linear segment of the plasma concentration time curve. Elimination half-life (T½) as follows: T½ = ln(2) / λZ Area under the curve will be calculated using the linear trapezoidal method and extrapolated to infinity using: AUCinf = AUClas
Interventions
- DRUG Lofexidine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-10 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01437306 record still lists
NCT01437306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Lofexidine HCl is the first listed.
NCT01437306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437306 about?
NCT01437306 is a clinical study titled "Lofexidine Food Effect Study in Healthy Volunteers". The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured by US WorldMeds, LLC.
What is the current status of trial NCT01437306?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-10. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01437306?
The interventions under investigation include: Lofexidine HCl (DRUG).
Who is sponsoring clinical trial NCT01437306?
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 NCT01437306's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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