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Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

Amphastar Pharmaceuticals, Inc. · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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asthmapharmacokinetics
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.
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