CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
15Nitrogen(15N)-labeled sodium nitrite +1 moredrug
Likely dose
15Nitrogen(15N)-labeled sodium nitrite 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01681836
NCT01681836Phase 1Completed
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An Open-Label Study of Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

Gladwin, Mark, MD·interventional·Posted Sep 10, 2012·Updated Sep 4, 2018

In Brief

A Phase 1 clinical trial evaluating 15Nitrogen(15N)-labeled sodium nitrite and 15Nitrogen(15N)-labeled sodium nitrate for Focus of Study of Healthy Adults. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocus of Study of Healthy Adults
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2012
Enrollment StartOct 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.8 years ago

Interventions

15Nitrogen(15N)-labeled sodium nitritedrug

15Nitrogen(15N)-labeled sodium nitrite 20 mg once

15Nitrogen(15N)-labeled sodium nitratedrug

15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once