Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Bronchospasm; Wheezing; Shortness of Breath
Intervention: Epinephrine Inhalation Aerosol, HFA (Drug); Epinephrine Inhalation Aerosol (Drug)
Phase: Phase 1/Phase 2
Sponsored by: Amphastar Pharmaceuticals, Inc.
Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Amphastar Pharmaceuticals, Inc.
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.
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)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Baseline Concentration (C0) of Total Epinephrine
Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Half-life (t1/2) of Total Epinephrine
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
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
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).
Minimum age: 18 Years.
Maximum age: 30 Years.
- Generally healthy at screening;
- No clinically significant respiratory, cardiovascular and other systemic or organic
- Body weight ≥ 50 kg for men and ≥ 45 kg for women,
- Sitting blood pressure ≤ 135/90 mm Hg;
- Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing
a clinically acceptable form of birth control;
- Properly consented
- Other criteria apply
- A smoking history of ≥10 pack-years, or having smoked within 6 months;
- Upper respiratory tract infections within 2 wk, or lower respiratory tract infection
within 4 wk, prior to Screening;
- Any current or recent respiratory conditions that might significantly affect
pharmacodynamic response to the study drugs;
- Known intolerance or hypersensitivity to the study MDI ingredients;
- Having been on other investigational studies, or donated blood, in the last 30 days;
- Other Criteria Apply
Locations and Contacts
Armstrong Study Site One, Cypress, California 90630, United States
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Starting date: August 2010
Last updated: October 21, 2014