drugset / Trial / NCT00814645
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-04
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Nitrite | Small molecule | 5 mg | Inhaled |
| Comparator | Sodium Nitrite | Small molecule | 15 mg | Inhaled |
| Comparator | Sodium Nitrite | Small molecule | 45 mg | Inhaled |
| Comparator | Sodium Nitrite | Small molecule | 113 mg | Inhaled |