At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)
In Brief
A Phase 2 clinical trial evaluating Epinephrine Inhalation Aerosol, HFA and Epinephrine Inhalation Aerosol for Asthma and 3 related conditions. Completed, enrolled 23 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation
Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations