Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
Status:
Terminated
Trial end date:
2012-11-01
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 to
complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK.
Safety of E004 will also be evaluated.