This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (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 and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Amphastar Study Site 1
Cypress, California, United States
Pharmacokinetics including maximum concentration and area under the curve
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time
Time frame: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.
Vital Signs
Systolic and Diastolic Blood pressure and heart rate
Time frame: within 30 min predose, at 30, 60 and 360 min postdose
12-lead Electrocardiogram (ECG)
12 lead ECG (Routine and QT/QTc intervals)
Time frame: within 30 min pre-dose, and at 15 and 120 min post-dose
Telemetry ECG
Telemetry recording of heart rate
Time frame: within 30 min pre-dose, and during the initial 5 min post-dose
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