drugset / Trial / NCT01143051
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
RandomizedCrossoverTriple-blindTreatment
Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epinephrine | Other / unclassified | 1.25 mg | Inhaled |
| Subject | Epinephrine | Other / unclassified | 1.6 mg | Inhaled |
| Subject | Epinephrine | Other / unclassified | 2.2 mg | Inhaled |