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NCT01681836 · ClinicalTrials.gov registry record · Phase 1
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
A Phase 1 study, sponsored by Gladwin, Mark, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01681836 is a Phase 1 study that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 11 participants.
The verdict
NCT01681836, a Phase 1 study, has completed, sponsored by Gladwin, Mark, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.
Interventions
- DRUG 15Nitrogen(15N)-labeled sodium nitrite
- DRUG 15Nitrogen(15N)-labeled sodium nitrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01681836
The ClinicalTrials.gov registry entry for NCT01681836 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gladwin, Mark, MD, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 15Nitrogen(15N)-labeled sodium nitrite is the first listed.
NCT01681836 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01681836 about?
NCT01681836 is a clinical study titled "Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults". This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokin...
What is the current status of trial NCT01681836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2012-10. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01681836?
The interventions under investigation include: 15Nitrogen(15N)-labeled sodium nitrite (DRUG), 15Nitrogen(15N)-labeled sodium nitrate (DRUG).
Who is sponsoring clinical trial NCT01681836?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
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