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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: Completed Phase 1 study, sponsored by Gladwin, Mark, MD.
NCT01681836 is a Phase 1 study that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
"Post-doses" refers to that subjects will receive a single dose of each study drug, oral 15Nitrogen(15N)-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period
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 |
What the finished NCT01681836 record still lists
NCT01681836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which 15Nitrogen(15N)-labeled sodium nitrite is the first listed.
NCT01681836 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681836's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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