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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 is a Phase 1 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01149629
The ClinicalTrials.gov registry entry for NCT01149629 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chelsea Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT01149629 reports 0 study locations.
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.
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