Conditions: Asthma
Keywords: Asthma Pharmacokinetics Epinephrine Bronchodilator metered dose inhaler
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Detailed description:
This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

* At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:

  * Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;
  * Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;
  * Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).
* PK blood samples will be taken from a vein at scheduled time points.
* Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Arms:
arm 1: Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. arm 2: T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation arm 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

Interventions: intervention 1: epinephrine inhalation aerosol intervention 2: epinephrine inhalation aerosol intervention 3: epinephrine inhalation aerosol
Intervention descriptions: intervention 1: Single dose 220 mcg/inhalation, 10 inhalations intervention 2: HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations intervention 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations

Protocol document: