Asthma Clinical Trial
Official title:
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)
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.
E004 is formulated with epinephrine free base as the active ingredient, and
hydrofluoroalkane (HFA-134a) as the propellant.
In order to differentiate the inhaled epinephrine from the fluctuating background of
endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine
(epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK
of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the
currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per
inhalation).
This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to
be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied using
E004-d3 at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine
CFC-MDI will be used as a Reference Control (Arm C).
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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