Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine
Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled
epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous
epinephrine, in healthy male and female adult volunteers. The current study is designed for a
more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated,
under augmented dose conditions.