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NCT01149629 · ClinicalTrials.gov registry record · Phase 1
Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa
A Phase 1 study, sponsored by Chelsea Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01149629: Completed Phase 1 study, sponsored by Chelsea Therapeutics.
NCT01149629 is a Phase 1 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01149629, a Phase 1 study, has completed, sponsored by Chelsea Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
One purpose of this study is to determine if taking droxidopa after eating will have an effect on how the body processes (absorbs and eliminates) the drug in healthy elderly subjects. Another purpose of this study is to see how the body processes (absorbs and eliminates) one 300mg capsule compared to three 100mg capsules. This study will also evaluate how well the body processes (absorbs and eliminates) and tolerates droxidopa when a 300 mg capsule is given 3 times a day for a total dose of 900 mg over the course of one day. Droxidopa is used to treat low blood pressure upon standing in patients with diseases of the nervous system, to prevent low blood pressure in patients with kidney disease during hemodialysis (removal of waste products of the blood), and to treat frozen gait (walking, stepping or running) and dizziness upon standing in patients with Parkinson's disease.
Primary Outcome
Blood samples will be collected at the time from 0 to 24 hours. Cmax, Tmax, AUC(0-∞), AUC(0-t), t1/2, and CL/F, will be determined for plasma concentrations of droxidopa in Parts I and II and will also be determined for two of its metabolites (3-OM-droxidopa and norepinephrine) in Part II only.
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT01149629 record still lists
NCT01149629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT01149629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01149629 about?
NCT01149629 is a clinical study titled "Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa". One purpose of this study is to determine if taking droxidopa after eating will have an effect on how the body processes (absorbs and eliminates) the drug in healthy elderly subjects. Another purpose of this study is to see how the body processes (absorbs and eliminates) one 300mg capsule compared t...
What is the current status of trial NCT01149629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01149629?
The interventions under investigation include: Droxidopa (DRUG).
Who is sponsoring clinical trial NCT01149629?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01149629's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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